Clinical Trials
Current List of Clinical Trials
ALS
Healey Platform Master Protocol
Healey Platform Master Protocol
HEALEY ALS: Task Order 1-Master Protocol
Principal Investigator: Edward Kasarskis, MD, PhD
Coordinator: Ryan Blood
Status: Open to enrollment
TITLE: HEALEY ALS PLATFORM TRIAL - MASTER PROTOCOL
STUDY OBJECTIVE: The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.
HEALEY ALS: Task Order 1-Master Protocol
Principal Investigator: Edward Kasarskis, MD, PhD
Coordinator: Ryan Blood
Status: Open to enrollment
TITLE: HEALEY ALS PLATFORM TRIAL - MASTER PROTOCOL
STUDY OBJECTIVE: The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. This trial is designed as a perpetual platform trial. This means that there is a single Master Protocol dictating the conduct of the trial. In this trial, multiple investigational products for ALS will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen. Each regimen consists of a placebo-controlled trial, meaning that the active investigational product and matching placebo will be tested in each regimen.
Regimen Specific Appendix A for Zilucoplan
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix A for Zilucoplan
Regimen Specific Appendix A for Zilucoplan
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix A for Zilucoplan
Regimen Specific Appendix B for Verdiperstat
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix B for Verdiperstat
Regimen Specific Appendix B for Verdiperstat
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix B for Verdiperstat
Regimen Specific Appendix C for CNM-Au8
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix C for CNM-Au8
Regimen Specific Appendix C for CNM-Au8
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix C for CNM-Au8
Regimen Specific Appendix D for Pridopidine
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed to Enrollment
Title: Regimen Specific Appendix D for Pridopidine
Regimen Specific Appendix D for Pridopidine
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed to Enrollment
Title: Regimen Specific Appendix D for Pridopidine
Regimen Specific Appendix E for Trehalose
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix E for Trehalose
Regimen Specific Appendix E for Trehalose
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Closed
Title: Regimen Specific Appendix E for Trehalose
Regimen Specific Appendix F for ABBV-CLS-7262
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Open to Enrollment
Title: Regimen Specific Appendix F for ABBV-CLS-7262
Regimen Specific Appendix F for ABBV-CLS-7262
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Open to Enrollment
Title: Regimen Specific Appendix F for ABBV-CLS-7262
Regimen-Specific Appendix G for DNL343
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Open to Enrollment
Title: Regimen-Specific Appendix G for DNL343
Regimen-Specific Appendix G for DNL343
Principal Investigator: Edward Kasarskis, MD
Coordinator: James Lewis
Status: Open to Enrollment
Title: Regimen-Specific Appendix G for DNL343
WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)
Principal Investigator: Vishakhadatta Mathur Kumaraswamy, MD
Coordinator: James Lewis
Status: Open to Enrollment
Title: A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)
WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)
Principal Investigator: Vishakhadatta Mathur Kumaraswamy, MD
Coordinator: James Lewis
Status: Open to Enrollment
Title: A Phase 2a Open-Label Preliminary Safety, Efficacy, and Biomarker Study of WP-0512 in Patients with Amyotrophic Lateral Sclerosis (ALS)
CIDP
ARGX-117-2402
Principal Investigator: Nakul Katyal, MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076 and James Lewis, James.Lewis9888@uky.edu, 859-218-2231
Status: Pending - Open to Enrollment
Title: A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Study Objective: The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP.
ARGX-117-2402
Principal Investigator: Nakul Katyal, MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076 and James Lewis, James.Lewis9888@uky.edu, 859-218-2231
Status: Pending - Open to Enrollment
Title: A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy
Study Objective: The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP.
Epilepsy
Neuropace PAS
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: Pat Arnold
Status: Closed to enrollment
TITLE: IMPLANTATION OF NEUROSTIMULATOR FOR REFRACTORY EPILEPSY IN SUBJECTS WHO FAILED ANTIEPILEPTIC DRUGS.
STUDY OBJECTIVE: To follow patients prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified Comprehensive Epilepsy Centers by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
Neuropace PAS
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: Pat Arnold
Status: Closed to enrollment
TITLE: IMPLANTATION OF NEUROSTIMULATOR FOR REFRACTORY EPILEPSY IN SUBJECTS WHO FAILED ANTIEPILEPTIC DRUGS.
STUDY OBJECTIVE: To follow patients prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the RNS System at qualified Comprehensive Epilepsy Centers by qualified neurologists, epileptologists, and neurosurgeons trained on the RNS System.
E2007-G000-410
Principal Investigator: Sally Mathias, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PERAMPANEL AS MONOTHERAPY OR FIRST ADJUNCTIVE THERAPY IN SUBJECTS WITH PARTIAL ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES OR WITH PRIMARY GENERALIZED TONIC-CLONIC SE
STUDY OBJECTIVE: To assess the retention rate of perampanel when given as monotherapy or 1st adjunctive therapy in subjects with partial-onset seizures (POS) or primary generalized tonic-clonic seizures (PGTCS).
E2007-G000-410
Principal Investigator: Sally Mathias, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PERAMPANEL AS MONOTHERAPY OR FIRST ADJUNCTIVE THERAPY IN SUBJECTS WITH PARTIAL ONSET SEIZURES WITH OR WITHOUT SECONDARILY GENERALIZED SEIZURES OR WITH PRIMARY GENERALIZED TONIC-CLONIC SE
STUDY OBJECTIVE: To assess the retention rate of perampanel when given as monotherapy or 1st adjunctive therapy in subjects with partial-onset seizures (POS) or primary generalized tonic-clonic seizures (PGTCS).
EP0092
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PADSEVONIL AS ADJUNCTIVE TREATMENT OF FOCAL-ONSET SEIZURES IN ADULT SUBJECTS WITH DRUG-RESISTANT EPILEPSY (PHASE 3 STUDY)
STUDY OBJECTIVE: The primary objective is to evaluate the efficacy of the 3 selected dose regimens of PSL administered concomitantly with up to 3 AEDs compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
EP0092
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PADSEVONIL AS ADJUNCTIVE TREATMENT OF FOCAL-ONSET SEIZURES IN ADULT SUBJECTS WITH DRUG-RESISTANT EPILEPSY (PHASE 3 STUDY)
STUDY OBJECTIVE: The primary objective is to evaluate the efficacy of the 3 selected dose regimens of PSL administered concomitantly with up to 3 AEDs compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy.
YKP3089C025
Principal Investigator: Siddharth Kapoor, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CENOBAMATE ADJUNCTIVE THERAPY IN SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES (PHASE 3 STUDY)
STUDY OBJECTIVE: To demonstrate the efficacy of adjunctive cenobamate 200 mg therapy compared with placebo on PGTC seizures.
YKP3089C025
Principal Investigator: Siddharth Kapoor, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CENOBAMATE ADJUNCTIVE THERAPY IN SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURES (PHASE 3 STUDY)
STUDY OBJECTIVE: To demonstrate the efficacy of adjunctive cenobamate 200 mg therapy compared with placebo on PGTC seizures.
YKP3089C033-1
Principal Investigator: Siddharth Kapoor, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: A MULTICENTER OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CENOBAMATE ADJUNCTIVE THERAPY IN SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURE
STUDY OBJECTIVE: To evaluate the safety and tolerability of cenobamate in subjects with PGTC seizures
YKP3089C033-1
Principal Investigator: Siddharth Kapoor, MD
Coordinator: Dawn Baker
Status: Closed to enrollment
TITLE: A MULTICENTER OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CENOBAMATE ADJUNCTIVE THERAPY IN SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURE
STUDY OBJECTIVE: To evaluate the safety and tolerability of cenobamate in subjects with PGTC seizures
RNS® System Post-Approval Study in Epilepsy
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: Pat Arnold, RN
Status: Closed to enrollment
Title: RNS® System Post-Approval Study in Epilepsy
RNS® System Post-Approval Study in Epilepsy
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: Pat Arnold, RN
Status: Closed to enrollment
Title: RNS® System Post-Approval Study in Epilepsy
XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Randomized, Double-blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Randomized, Double-blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
XEN1101 in Adults Diagnosed With Epilepsy
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Adults Diagnosed With Epilepsy
XEN1101 in Adults Diagnosed With Epilepsy
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Adults Diagnosed With Epilepsy
Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
Principal Investigator: Meriem Bensalem-Owen, MD
Coordinator: James Lewis
Status: Open to enrollment
Title: An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures
XACKT
Principal Investigator: Meriem Bensalem-Owen, M.D
Coordinator: James Lewis, james.lewis9888@uky.edu |859-218-2231
Status: Open to enrollment
Title: A Randomized Study of XEN1101 Versus Placebo in Primary Generalized Tonic-Clonic Seizures
Study Objective: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in participants ≥12 years of age from different geographic regions, diagnosed with generalized epilepsy and experiencing probable or possible PGTCS (with or without other subtypes of generalized seizures), and taking 1 to 3 ASMs.
XACKT
Principal Investigator: Meriem Bensalem-Owen, M.D
Coordinator: James Lewis, james.lewis9888@uky.edu |859-218-2231
Status: Open to enrollment
Title: A Randomized Study of XEN1101 Versus Placebo in Primary Generalized Tonic-Clonic Seizures
Study Objective: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in participants ≥12 years of age from different geographic regions, diagnosed with generalized epilepsy and experiencing probable or possible PGTCS (with or without other subtypes of generalized seizures), and taking 1 to 3 ASMs.
XTOLE4
Principal Investigator: Meriem Bensalem-Owen, M.D.
Coordinator: James Lewis, james.lewis9888@uky.edu |859-218-2231
Status: Open to Enrollment
Title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
Study Objective: This is an OLE study of Phase 3 clinical studies: X-TOLE2, X-TOLE3, and X-ACKT. This study will evaluate the long-term safety, tolerability, PK, and efficacy of XEN1101 taken orally QD in subjects with FOS or PGTCS for the treatment of seizures for up to 3 years.
XTOLE4
Principal Investigator: Meriem Bensalem-Owen, M.D.
Coordinator: James Lewis, james.lewis9888@uky.edu |859-218-2231
Status: Open to Enrollment
Title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
Study Objective: This is an OLE study of Phase 3 clinical studies: X-TOLE2, X-TOLE3, and X-ACKT. This study will evaluate the long-term safety, tolerability, PK, and efficacy of XEN1101 taken orally QD in subjects with FOS or PGTCS for the treatment of seizures for up to 3 years.
Genetics
ITF-2357-62
Principal Investigator: David Neil Toupin, M.D.
Coordinator: James Lewis, james.lewis9888@uky.edu |859-218-2231
Status: Pending Open to Enrollment
Title: A Prospective, Observational Study Evaluating the Real-World Experience of Givinostat in Patients with Duchenne Muscular Dystrophy
Study Objective: This is a prospective, observational study evaluating the real-world experience of givinostat in patients with DMD
ITF-2357-62
Principal Investigator: David Neil Toupin, M.D.
Coordinator: James Lewis, james.lewis9888@uky.edu |859-218-2231
Status: Pending Open to Enrollment
Title: A Prospective, Observational Study Evaluating the Real-World Experience of Givinostat in Patients with Duchenne Muscular Dystrophy
Study Objective: This is a prospective, observational study evaluating the real-world experience of givinostat in patients with DMD
Headache
Galcanezumab (6 to 17 year olds)
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (REBUILD-1)
Study Objective: The main purpose of this study is to evaluate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Galcanezumab (6 to 17 year olds)
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine (REBUILD-1)
Study Objective: The main purpose of this study is to evaluate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Galcanezumab (12 to 17 year olds)
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - (REBUILD-2)
Study Objective: The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Galcanezumab (12 to 17 year olds)
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - (REBUILD-2)
Study Objective: The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
Lasmiditan
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
Study Objective: The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
Lasmiditan
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
Study Objective: The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
Lasmiditan
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine PIONEER-PEDS1
Study Objective: The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
Lasmiditan
Principal Investigator: Sharoon Qaiser, MD Lexington, KY
Coordinator:
Status: Open to Enrollment
Title: A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine PIONEER-PEDS1
Study Objective: The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
NEURO-24-PERISCOPE-1
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor, matt.taylor@uky.edu, 502-961-6047
Status: Open to enrollment
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Study Objective: The hypothesis and primary objective is that treatment with ubrogepant in pediatric subjects is well tolerated, has an acceptable safety profile, and provides a clinically meaningful reduction in pain following administration of the initial dose of ubrogepant in subjects 6 to 17 years of age.
NEURO-24-PERISCOPE-1
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor, matt.taylor@uky.edu, 502-961-6047
Status: Open to enrollment
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Study Objective: The hypothesis and primary objective is that treatment with ubrogepant in pediatric subjects is well tolerated, has an acceptable safety profile, and provides a clinically meaningful reduction in pain following administration of the initial dose of ubrogepant in subjects 6 to 17 years of age.
NEURO-24-PERISCOPE-2
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor, matt.taylor@uky.edu, 502-961-6047
Status: Open to enrollment
Title: A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Study Objective: To evaluate the long-term safety and tolerability of ubrogepant for the acute treatment of migraine in pediatric subjects aged 6 to 17 years.
NEURO-24-PERISCOPE-2
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor, matt.taylor@uky.edu, 502-961-6047
Status: Open to enrollment
Title: A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Study Objective: To evaluate the long-term safety and tolerability of ubrogepant for the acute treatment of migraine in pediatric subjects aged 6 to 17 years.
C5301024
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Renee Wagner, renee.wagner@uky.edu, 859-323-0028
Status: In start-up
Title: An Interventional Efficacy, Safety, and Tolerability, Phase 3, Double-Blind, 2-ARM Crossover Study With An Open-Label Extension to Investigate the Acute Treatment of Migraine (With or Without Aura) With Intranasal Zavegepant Compared With Placebo in Participants 6 to Less Than 18 Years of Age
Study Objective: To evaluate the efficacy of zavegepant compared with placebo in the acute treatment of migraine.
C5301024
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Renee Wagner, renee.wagner@uky.edu, 859-323-0028
Status: In start-up
Title: An Interventional Efficacy, Safety, and Tolerability, Phase 3, Double-Blind, 2-ARM Crossover Study With An Open-Label Extension to Investigate the Acute Treatment of Migraine (With or Without Aura) With Intranasal Zavegepant Compared With Placebo in Participants 6 to Less Than 18 Years of Age
Study Objective: To evaluate the efficacy of zavegepant compared with placebo in the acute treatment of migraine.
Movement Disorder
APNG - Project IV
Principal Investigator: Craig van Horne, MD, PhD
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: CONTINUATION OF A PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF IMPLANTING AUTOLOGOUS PERIPHERAL NERVE GRAFTS IN SUBJECTS WITH PARKINSON’S DISEASE UNDERGOING DEEP BRAIN STIMULATION SURGERY AND TREATMENT: MULTISITE-DELIVERY SUB-STUDY
APNG - Project IV
Principal Investigator: Craig van Horne, MD, PhD
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: CONTINUATION OF A PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF IMPLANTING AUTOLOGOUS PERIPHERAL NERVE GRAFTS IN SUBJECTS WITH PARKINSON’S DISEASE UNDERGOING DEEP BRAIN STIMULATION SURGERY AND TREATMENT: MULTISITE-DELIVERY SUB-STUDY
BouNDless study – ND0612-317
Principal Investigator: John Slevin, MD
Coordinator: Michael Nsoesie / Renee Wagner
Status: Open to enrollment
TITLE: A MULTI-CENTER, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP CLINICAL TRIAL, INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF CONTINUOUS SUBCUTANEOUS ND0612 INFUSION IN COMPARISON TO ORAL IR-LD/CD IN SUBJECTS WITH PARKIN
STUDY OBJECTIVE: The primary objective of the study is to determine the effect of ND0612 on daily ON time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and ON time with non-troublesome dyskinesia) using subject-completed ON/OFF diary assessments of motor function in subjects with Parkinson s disease (PD) experiencing motor fluctuations.
BouNDless study – ND0612-317
Principal Investigator: John Slevin, MD
Coordinator: Michael Nsoesie / Renee Wagner
Status: Open to enrollment
TITLE: A MULTI-CENTER, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP CLINICAL TRIAL, INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF CONTINUOUS SUBCUTANEOUS ND0612 INFUSION IN COMPARISON TO ORAL IR-LD/CD IN SUBJECTS WITH PARKIN
STUDY OBJECTIVE: The primary objective of the study is to determine the effect of ND0612 on daily ON time without troublesome dyskinesia (defined as the sum of "ON" time without dyskinesia and ON time with non-troublesome dyskinesia) using subject-completed ON/OFF diary assessments of motor function in subjects with Parkinson s disease (PD) experiencing motor fluctuations.
DBS Eval
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: EVALUATION OF DEEP BRAIN STIMULATION THERAPY IN PATIENTS WITH PARKINSON’S DISEASE. THE PURPOSE OF THIS STUDY IS TO FOLLOW THE PROGRESSION OF PARKINSON’S DISEASE IN PEOPLE WHO HAVE RECEIVED DBS AND EXAMINE DBS THERAPY IN PATIENTS WHO HAVE HAD DBS FOR AT LE
DBS Eval
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: EVALUATION OF DEEP BRAIN STIMULATION THERAPY IN PATIENTS WITH PARKINSON’S DISEASE. THE PURPOSE OF THIS STUDY IS TO FOLLOW THE PROGRESSION OF PARKINSON’S DISEASE IN PEOPLE WHO HAVE RECEIVED DBS AND EXAMINE DBS THERAPY IN PATIENTS WHO HAVE HAD DBS FOR AT LE
Molecular and Functional Biomarkers of Parkinson's Disease
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner
Status: Open to enrollment
Molecular and Functional Biomarkers of Parkinson's Disease
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner
Status: Open to enrollment
phMRI
Principal Investigator: Zain Guduru, MD
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: A PILOT STUDY TO EXAMINE APOMORPHINE-INDUCED BOLD ACTIVATION IN PATIENTS WITH PARKINSON’S DISEASE.
phMRI
Principal Investigator: Zain Guduru, MD
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: A PILOT STUDY TO EXAMINE APOMORPHINE-INDUCED BOLD ACTIVATION IN PATIENTS WITH PARKINSON’S DISEASE.
RAD-PD
Principal Investigator: Zain Guduru, MD
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: REGISTRY FOR THE ADVANCEMENT OF DBS IN PARKINSON’S DISEASE
RAD-PD
Principal Investigator: Zain Guduru, MD
Coordinator: Morgan Yazell
Status: Open to enrollment
TITLE: REGISTRY FOR THE ADVANCEMENT OF DBS IN PARKINSON’S DISEASE
TOPAZ
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner
Status: Open to enrollment
TITLE: TRIAL OF PARKINSON'S AND ZOLEDRONIC ACID (TOPAZ)
STUDY OBJECTIVE: This home-based randomized clinical trial is designed to test the efficacy of ZA-5 mg in Parkinson's disease (PD) and parkinsonism patients. This trial will also address barriers to treatment of patients with PD and parkinsonism by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD and parkinsonism, simplifying treatment by giving ZA at home without extra medical visits and BMD testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures.
TOPAZ
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner
Status: Open to enrollment
TITLE: TRIAL OF PARKINSON'S AND ZOLEDRONIC ACID (TOPAZ)
STUDY OBJECTIVE: This home-based randomized clinical trial is designed to test the efficacy of ZA-5 mg in Parkinson's disease (PD) and parkinsonism patients. This trial will also address barriers to treatment of patients with PD and parkinsonism by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD and parkinsonism, simplifying treatment by giving ZA at home without extra medical visits and BMD testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures.
TOPAZ Study
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner
Status: Open to enrollment
TITLE: TOPAZ (TRIAL OF PARKINSON'S AND ZOLEDRONIC ACID). REFERRAL SITE FOR STUDY.
STUDY OBJECTIVE: To test the efficacy of a single infusion of zoledronic acid 5 mg compared with placebo given at home to reduce the risk of clinical fractures after 2 years and 5 years of follow-up.
TOPAZ Study
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner
Status: Open to enrollment
TITLE: TOPAZ (TRIAL OF PARKINSON'S AND ZOLEDRONIC ACID). REFERRAL SITE FOR STUDY.
STUDY OBJECTIVE: To test the efficacy of a single infusion of zoledronic acid 5 mg compared with placebo given at home to reduce the risk of clinical fractures after 2 years and 5 years of follow-up.
APNG
Principal Investigator: Craig van Horne, MD, PhD
Coordinator: Morgan Yazell
Status: Closed to enrollment
TITLE: A PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF IMPLANTING AUTOLOGOUS PERIPHERAL NERVE GRAFTS INTO THE SUBSTANTIA NIGRA OF SUBJECTS WITH PARKINSON’S DISEASE UNDERGOING DEEP BRAIN STIMULATION SURGERY AND TREATMENT.
APNG
Principal Investigator: Craig van Horne, MD, PhD
Coordinator: Morgan Yazell
Status: Closed to enrollment
TITLE: A PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF IMPLANTING AUTOLOGOUS PERIPHERAL NERVE GRAFTS INTO THE SUBSTANTIA NIGRA OF SUBJECTS WITH PARKINSON’S DISEASE UNDERGOING DEEP BRAIN STIMULATION SURGERY AND TREATMENT.
APNG2
Principal Investigator: Craig van Horne, MD, PhD
Coordinator: Morgan Yazell
Status: Closed to enrollment
TITLE: CONTINUATION OF A PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF IMPLANTING AUTOLOGOUS PERIPHERAL NERVE GRAFTS IN SUBJECTS WITH PARKINSON’S DISEASE UNDERGOING DEEP BRAIN STIMULATION SURGERY AND TREATMENT.
APNG2
Principal Investigator: Craig van Horne, MD, PhD
Coordinator: Morgan Yazell
Status: Closed to enrollment
TITLE: CONTINUATION OF A PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF IMPLANTING AUTOLOGOUS PERIPHERAL NERVE GRAFTS IN SUBJECTS WITH PARKINSON’S DISEASE UNDERGOING DEEP BRAIN STIMULATION SURGERY AND TREATMENT.
DAT Binding
Principal Investigator: Julie Gurwell, PhD, PA-C.
Coordinator: Morgan Yazell
Status: Closed to enrollment
TITLE: EXPLORING DOPAMINE TRANSPORTER SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY QUANTIFICATION AS A MEASURE OF DISEASE PROGRESSION IN IDIOPATHIC PARKINSON’S DISEASE.
DAT Binding
Principal Investigator: Julie Gurwell, PhD, PA-C.
Coordinator: Morgan Yazell
Status: Closed to enrollment
TITLE: EXPLORING DOPAMINE TRANSPORTER SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY QUANTIFICATION AS A MEASURE OF DISEASE PROGRESSION IN IDIOPATHIC PARKINSON’S DISEASE.
PDgene (NEURO-21-PDGENE)
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Renee Wagner
Status: Open to enrollment
Description: Free genetic testing of Parkinson's disease patients for 7 of the most common Parkinson's gene mutations with free genetic counseling provided by phone. This is a multicenter study sponsored by the Parkinson's Foundation.
PDgene (NEURO-21-PDGENE)
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Renee Wagner
Status: Open to enrollment
Description: Free genetic testing of Parkinson's disease patients for 7 of the most common Parkinson's gene mutations with free genetic counseling provided by phone. This is a multicenter study sponsored by the Parkinson's Foundation.
Biomarkers in Parkinson's Disease
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Open to enrollment
Description: Study to identify biomarkers in blood, saliva or urine of patients with Parkinson's disease to help predict changes in thinking/cognition. This involves a baseline research visit and then a visit at 2-year timepoints. Spouses or patients with no neurologic conditions are also eligible to enroll as controls for comparison. This is an NIH- funded study.
Biomarkers in Parkinson's Disease
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Open to enrollment
Description: Study to identify biomarkers in blood, saliva or urine of patients with Parkinson's disease to help predict changes in thinking/cognition. This involves a baseline research visit and then a visit at 2-year timepoints. Spouses or patients with no neurologic conditions are also eligible to enroll as controls for comparison. This is an NIH- funded study.
NEURO-23-BIA 28-6156
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Closed to enrollment
Description: Phase 2 trial to test a disease modifying therapy in Parkinson's patients with Glucocerebrosidase (GBA1) Gene mutation.
NEURO-23-BIA 28-6156
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Closed to enrollment
Description: Phase 2 trial to test a disease modifying therapy in Parkinson's patients with Glucocerebrosidase (GBA1) Gene mutation.
Biofluid Markers in REM Behavior
Principal Investigator: Daniel Lee MD/Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Open to enrollment
Title: Predicting the Development of Neurodegenerative disorders through saliva biomarkers in patients with REM sleep behavior disorder.
Description: Patients with a diagnosis of REM sleep behavior disorder are tested at a baseline visit and approximate 1 year research visit to try to determine markers in blood, or saliva that help predict conversion to Parkinson's disease or other neurodegenerative conditions.
Biofluid Markers in REM Behavior
Principal Investigator: Daniel Lee MD/Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Open to enrollment
Title: Predicting the Development of Neurodegenerative disorders through saliva biomarkers in patients with REM sleep behavior disorder.
Description: Patients with a diagnosis of REM sleep behavior disorder are tested at a baseline visit and approximate 1 year research visit to try to determine markers in blood, or saliva that help predict conversion to Parkinson's disease or other neurodegenerative conditions.
RELIANCE: The Syn-Sleep Study
Principal Investigator: Daniel Lee MD
Coordinator: Matt Taylor
Status: Open to enrollment
Description: This is a multicenter study of patients with REM behavior disorder to determine if skin biopsy testing has good sensitivity and specificity in the disease and whether it can help predict conversion to Parkinson's disease or other neurologic diseases. This study involves 1 research visit per year for 3 years with skin tests and research testing at each visit.
RELIANCE: The Syn-Sleep Study
Principal Investigator: Daniel Lee MD
Coordinator: Matt Taylor
Status: Open to enrollment
Description: This is a multicenter study of patients with REM behavior disorder to determine if skin biopsy testing has good sensitivity and specificity in the disease and whether it can help predict conversion to Parkinson's disease or other neurologic diseases. This study involves 1 research visit per year for 3 years with skin tests and research testing at each visit.
APLO-1201
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, renee.wagner@uky.edu, 859-323-0028
Status: Open to Enrollment
Title: Phase 2, double-blind, placebo-controlled study to evaluate the effectiveness of two doses of AP-472 as adjunctive therapy to levodopa in Parkinson’s disease (PD) participants with motor fluctuations
Study Objective: Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo.
https://clinicaltrials.gov/study/NCT07432958?term=APLO-1201&viewType=Card
APLO-1201
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, renee.wagner@uky.edu, 859-323-0028
Status: Open to Enrollment
Title: Phase 2, double-blind, placebo-controlled study to evaluate the effectiveness of two doses of AP-472 as adjunctive therapy to levodopa in Parkinson’s disease (PD) participants with motor fluctuations
Study Objective: Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo.
https://clinicaltrials.gov/study/NCT07432958?term=APLO-1201&viewType=Card
CNIO752A12301 - PRESERVE
Principal Investigator: John Slevin, MD
Coordinator: Lynne Cagle, lynne.cagle@uky.edu, 859-218-5443
Status: Open to Enrollment
Title: A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension
Study Objective: To evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP). Eligible participants will be randomized to receive either NIO752 or placebo followed by an open-label extension.
CNIO752A12301 - PRESERVE
Principal Investigator: John Slevin, MD
Coordinator: Lynne Cagle, lynne.cagle@uky.edu, 859-218-5443
Status: Open to Enrollment
Title: A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension
Study Objective: To evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy (PSP). Eligible participants will be randomized to receive either NIO752 or placebo followed by an open-label extension.
BIOMARKER’S IN PARKINSONS DISEASE
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076
Status: Open to Enrollment
Title: Research for Discovering Biosample-Based Biomarkers in Parkinson’s Disease Patients and Repository
Description: This study aims to better understand the biological changes involved in Parkinson’s disease and related conditions, and how they affect movement and thinking. Participants will provide blood and other body fluid samples and undergo evaluations of motor symptoms both on and off Parkinson’s medications. The study also includes assessments of non-motor symptoms, along with tests of thinking and mood to evaluate cognitive function. The goal is to identify biomarkers that might help us predict changes in cognition associated with Parkinson's and ultimately develop therapies to prevent progression.
BIOMARKER’S IN PARKINSONS DISEASE
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076
Status: Open to Enrollment
Title: Research for Discovering Biosample-Based Biomarkers in Parkinson’s Disease Patients and Repository
Description: This study aims to better understand the biological changes involved in Parkinson’s disease and related conditions, and how they affect movement and thinking. Participants will provide blood and other body fluid samples and undergo evaluations of motor symptoms both on and off Parkinson’s medications. The study also includes assessments of non-motor symptoms, along with tests of thinking and mood to evaluate cognitive function. The goal is to identify biomarkers that might help us predict changes in cognition associated with Parkinson's and ultimately develop therapies to prevent progression.
DD201101
Principal Investigator: John Slevin, MD
Coordinator: Lynne Cagle, lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses following Stereotactic Intracranial Implantation of DSP-1083 into Subjects with Parkinson’s Disease
Study Objective: To evaluate the safety of DSP-1083 based on adverse events (AEs), changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks.
https://clinicaltrials.gov/study/NCT06753331?term=DSP-1083&rank=1
DD201101
Principal Investigator: John Slevin, MD
Coordinator: Lynne Cagle, lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses following Stereotactic Intracranial Implantation of DSP-1083 into Subjects with Parkinson’s Disease
Study Objective: To evaluate the safety of DSP-1083 based on adverse events (AEs), changes in neuropsychiatric/cognition status, and serial neuroimaging (ie, engraftment status, graft expansion, rejection) over 104 weeks.
https://clinicaltrials.gov/study/NCT06753331?term=DSP-1083&rank=1
NEU-411-PD201
Principal Investigator: John Slevin, MD
Coordinator: Lynne Cagle, lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease (NEULARK)
Study Objective: To evaluate the safety and primary efficacy of NEU-411 in participants with leucine-rich repeat kinase 2 (LRRK2)-driven Parkinson’s disease (PD)
https://clinicaltrials.gov/study/NCT06680830?term=NEU-411-PD201&rank=1
NEU-411-PD201
Principal Investigator: John Slevin, MD
Coordinator: Lynne Cagle, lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease (NEULARK)
Study Objective: To evaluate the safety and primary efficacy of NEU-411 in participants with leucine-rich repeat kinase 2 (LRRK2)-driven Parkinson’s disease (PD)
https://clinicaltrials.gov/study/NCT06680830?term=NEU-411-PD201&rank=1
PD Gene (NEURO-21-PDGENE)
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Renee Wagner – renee.wagner@uky.edu 859-323-0028
Status: Open to enrollment
Description: Free genetic testing of Parkinson's disease patients for 7 of the most common Parkinson's gene mutations with free genetic counseling provided by phone. This is a multicenter study sponsored by the Parkinson's Foundation.
PD Gene (NEURO-21-PDGENE)
Principal Investigator: Tritia Yamasaki MD PhD
Coordinator: Renee Wagner – renee.wagner@uky.edu 859-323-0028
Status: Open to enrollment
Description: Free genetic testing of Parkinson's disease patients for 7 of the most common Parkinson's gene mutations with free genetic counseling provided by phone. This is a multicenter study sponsored by the Parkinson's Foundation.
STAR (Neuro-24-STAR)
Principal Investigator: Craig van Horne, MD PhD
Coordinator: Jaimie Hixson – Jaimie.henderson@uky.edu 859-323-1908
Status: Open to enrollment
Title: Phase I randomized, double-blind study to evaluate feasibility, safety, and clinical responses of implanting autologous peripheral nerve tissue into the nucleus basalis of Meynert or substantia nigra for non-motor or motor symptoms in patients with Parkinson's disease undergoing DBS surgery (STAR) Trial
Study Objective: To evaluate the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra (SN) or nucleus basalis of Meynert (NBM) in individuals with Parkinson’s disease undergoing DBS surgery. Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment and at defined intervals post-surgery.
STAR (Neuro-24-STAR)
Principal Investigator: Craig van Horne, MD PhD
Coordinator: Jaimie Hixson – Jaimie.henderson@uky.edu 859-323-1908
Status: Open to enrollment
Title: Phase I randomized, double-blind study to evaluate feasibility, safety, and clinical responses of implanting autologous peripheral nerve tissue into the nucleus basalis of Meynert or substantia nigra for non-motor or motor symptoms in patients with Parkinson's disease undergoing DBS surgery (STAR) Trial
Study Objective: To evaluate the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra (SN) or nucleus basalis of Meynert (NBM) in individuals with Parkinson’s disease undergoing DBS surgery. Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment and at defined intervals post-surgery.
LEAP (Neuro-24-LEAP)
Principal Investigator: Craig van Horne, MD PhD
Coordinator: Jaimie Hixson – Jaimie.henderson@uky.edu 859-323-1908
Status: Open to enrollment
Title: A Phase I study of the feasibility and safety of SuraL nervE tissue grafting to the substantia nigrA in Patients with synucleinopathies (LEAP)
Study Objective: To evaluate clinical changes in PD and MSA through 1 year and surgery of participants in this placebo-controlled, double-blind trial of bilaterally implanting peripheral nerve tissue to the substantia nigra.
LEAP (Neuro-24-LEAP)
Principal Investigator: Craig van Horne, MD PhD
Coordinator: Jaimie Hixson – Jaimie.henderson@uky.edu 859-323-1908
Status: Open to enrollment
Title: A Phase I study of the feasibility and safety of SuraL nervE tissue grafting to the substantia nigrA in Patients with synucleinopathies (LEAP)
Study Objective: To evaluate clinical changes in PD and MSA through 1 year and surgery of participants in this placebo-controlled, double-blind trial of bilaterally implanting peripheral nerve tissue to the substantia nigra.
Multiple Sclerosis
Click-MS
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: CLADRIBINE TABLETS FOR RELAPSING MS PATIENTS WITH PREVIOUS SUBOPTIMAL RESPONSE TO INJECTABLE DISEASE MODIFYING THERAPIES.
STUDY OBJECTIVE: To estimate the annualized relapse rate (ARR) over a 24-month period in patients with RMS who are treated with cladribine tablets in a real-world setting and after suboptimal response to any injectable DMD approved in the United States for RMS
Click-MS
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: CLADRIBINE TABLETS FOR RELAPSING MS PATIENTS WITH PREVIOUS SUBOPTIMAL RESPONSE TO INJECTABLE DISEASE MODIFYING THERAPIES.
STUDY OBJECTIVE: To estimate the annualized relapse rate (ARR) over a 24-month period in patients with RMS who are treated with cladribine tablets in a real-world setting and after suboptimal response to any injectable DMD approved in the United States for RMS
Diagnosing Optic Neuritis with or Without Diagnosis of MS or NMOSD
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: DIAGNOSING OPTIC NEURITIS WITH OR WITHOUT DIAGNOSIS OF MS OR NMOSD - USING REFLEX APP AND NEUROLIGHT PUPILOMETER IN PATIENTS WITH KNOWN CASES OF ON (WITH OR WITHOUT MS/NMOSD) TO SEE IF IT WOULD BE EFFECTIVE IN MONITORING DISEASE PROGRESSION.
Diagnosing Optic Neuritis with or Without Diagnosis of MS or NMOSD
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: DIAGNOSING OPTIC NEURITIS WITH OR WITHOUT DIAGNOSIS OF MS OR NMOSD - USING REFLEX APP AND NEUROLIGHT PUPILOMETER IN PATIENTS WITH KNOWN CASES OF ON (WITH OR WITHOUT MS/NMOSD) TO SEE IF IT WOULD BE EFFECTIVE IN MONITORING DISEASE PROGRESSION.
Fundus Photography and MS
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: USING FUNDUS PHOTOGRAPHY TO LOOK AT DISEASE STATE IN MS PATIENTS.
Fundus Photography and MS
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: USING FUNDUS PHOTOGRAPHY TO LOOK AT DISEASE STATE IN MS PATIENTS.
MS and NMOSD in African American patients
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: DATA COLLECTION OF PATIENTS WITH MS AND/OR NMOSD AT KNI TO TRACK DISEASE PROGRESSION.
MS and NMOSD in African American patients
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: DATA COLLECTION OF PATIENTS WITH MS AND/OR NMOSD AT KNI TO TRACK DISEASE PROGRESSION.
Retinal imaging in MS and NMOSD
Principal Investigator: Jagannadha Avasarala, MD / Padmaja Sudhakar, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: DATA COLLECTION FROM PATIENTS OF DR. AVASARALA AND DR. SUDHAKAR WITH THESE DISEASES (WE HAVE WAIVER OF INFORMED CONSENT FOR THIS STUDY).
Retinal imaging in MS and NMOSD
Principal Investigator: Jagannadha Avasarala, MD / Padmaja Sudhakar, MD
Coordinator: Amanda Wilburn
Status: Open to enrollment
TITLE: DATA COLLECTION FROM PATIENTS OF DR. AVASARALA AND DR. SUDHAKAR WITH THESE DISEASES (WE HAVE WAIVER OF INFORMED CONSENT FOR THIS STUDY).
Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Kai Su
Status: Open to enrollment
TITLE: A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants with B-cell Mediated Autoimmune Disorders
Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel
Principal Investigator: Jagannadha Avasarala, MD
Coordinator: Kai Su
Status: Open to enrollment
TITLE: A Phase 1, Open-label Study to Evaluate the Safety and Clinical Activity of Azercabtagene Zapreleucel in Participants with B-cell Mediated Autoimmune Disorders
Zenas ZB020-03-002
Principal Investigator: Jagannadha Avasarala MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-859-218-5076
Status: Open to Enrollment
Title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients with Non-active Secondary Progressive Multiple Sclerosis
Study Objective: A phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with naSPMS.
Zenas ZB020-03-002
Principal Investigator: Jagannadha Avasarala MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-859-218-5076
Status: Open to Enrollment
Title: A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients with Non-active Secondary Progressive Multiple Sclerosis
Study Objective: A phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with naSPMS.
Myasthenia Gravis
ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
Principal Investigator: Ima Ebong, MD
Coordinator: Kai Su
Status: Open to enrollment
Title: The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: A Validation Study
ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis
Principal Investigator: Ima Ebong, MD
Coordinator: Kai Su
Status: Open to enrollment
Title: The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: A Validation Study
Telitacicept in Patients with Generalized Myasthenia Gravis
Principal Investigator: Zabeen Mahuwala, MD
Coordinator: Kai Su
Status: Open to enrollment
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis.
Telitacicept in Patients with Generalized Myasthenia Gravis
Principal Investigator: Zabeen Mahuwala, MD
Coordinator: Kai Su
Status: Open to enrollment
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis.
Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
Principal Investigator: Zabeen Mahuwala, MD
Coordinator: Corisa Logan, RN
Status: Open to enrollment
Title: A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
Principal Investigator: Zabeen Mahuwala, MD
Coordinator: Corisa Logan, RN
Status: Open to enrollment
Title: A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
IMVT-1402-3101(PROPEL)
Principal Investigator: Zabeen Mahuwala MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076
Status: Open to Enrollment
Title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis
Study Objective: To assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis who are antibody positive. A limited number of antibody negative patients will be enrolled. Patients will receive IMVT-1402 600mg, or IMVT-1402 300mg, for up to 26 weeks. Participants who complete Week 26 visit will be offered the option to join an OLE where all participants will receive IMVT-1402.
IMVT-1402-3101(PROPEL)
Principal Investigator: Zabeen Mahuwala MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076
Status: Open to Enrollment
Title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis
Study Objective: To assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis who are antibody positive. A limited number of antibody negative patients will be enrolled. Patients will receive IMVT-1402 600mg, or IMVT-1402 300mg, for up to 26 weeks. Participants who complete Week 26 visit will be offered the option to join an OLE where all participants will receive IMVT-1402.
RC18G006
Principal Investigator: Zabeen Mahuwala, MD
Coordinator: James Lewis, james.lewis9888@uky.edu, 859-218-2231
Status: Open to Enrollment
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis
Study Objective: A randomized, double-blind, placebo-controlled, parallel, multicenter, interventional Phase 3 study with an open-label extension (OLE) period to evaluate the efficacy and safety of telitacicept in patients with gMG. The total duration of the study is up to 84 weeks.
RC18G006
Principal Investigator: Zabeen Mahuwala, MD
Coordinator: James Lewis, james.lewis9888@uky.edu, 859-218-2231
Status: Open to Enrollment
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study with an Open-label Extension Period to Evaluate the Efficacy and Safety of Telitacicept in Patients with Generalized Myasthenia Gravis
Study Objective: A randomized, double-blind, placebo-controlled, parallel, multicenter, interventional Phase 3 study with an open-label extension (OLE) period to evaluate the efficacy and safety of telitacicept in patients with gMG. The total duration of the study is up to 84 weeks.
RNAC-MG-0029(AURORA)
Principal Investigator: Zabeen Mahuwala MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076
Status: Opens February 2026
Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)
Description: The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months. For eligible participants, Part 2 will last around 8 months.
RNAC-MG-0029(AURORA)
Principal Investigator: Zabeen Mahuwala MD
Coordinator: Corisa Logan, corisa.logan@uky.edu, 859-218-5076
Status: Opens February 2026
Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)
Description: The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months. For eligible participants, Part 2 will last around 8 months.
NeuroBank
NeuroBank
Principal Investigator: Tritia Yamasaki, MD, PhD
Contact: Bibi Broome, Laura Muzinic
Status: Open to enrollment
TITLE: NEUROBANK
STUDY OBJECTIVE: The purpose of Neurobank is to build a repository of human samples to advance research in neurologic conditions. In collaboration with Neuroscience researchers across campus and outside institutions, the purpose of Neurobank is to aid research that helps advance understanding, biomarkers and new therapeutics for neurologic conditions. Typically this just involves a blood draw. For patients undergoing surgery or procedures such as lumbar puncture, Neurobank can bank leftover nervous system tissue or CSF fluid obtained for clinical reasons. People above the age of 2 with neurologic conditions, as well as healthy controls are eligible. Neurobank is supported by the Neuroscience Research Priority Area at UK.
NeuroBank
Principal Investigator: Tritia Yamasaki, MD, PhD
Contact: Bibi Broome, Laura Muzinic
Status: Open to enrollment
TITLE: NEUROBANK
STUDY OBJECTIVE: The purpose of Neurobank is to build a repository of human samples to advance research in neurologic conditions. In collaboration with Neuroscience researchers across campus and outside institutions, the purpose of Neurobank is to aid research that helps advance understanding, biomarkers and new therapeutics for neurologic conditions. Typically this just involves a blood draw. For patients undergoing surgery or procedures such as lumbar puncture, Neurobank can bank leftover nervous system tissue or CSF fluid obtained for clinical reasons. People above the age of 2 with neurologic conditions, as well as healthy controls are eligible. Neurobank is supported by the Neuroscience Research Priority Area at UK.
Optic Neuropathy / Neuritis
NEURITIS - PR-5301 – PIONEER-1
Principal Investigator: Padmaja Sudhakar, MD
Coordinator: James Lewis, james.lewis9888@uky.edu, 859-218-2231
Status: Open September 2026
Title: A Randomized, Double-Masked, Placebo-Controlled Study Assessing The Efficacy And Safety Of Privosegtor (Ocs-05) In Patients With Optic Neuritis (ON)
Study Objective: The Pioneer-1 study is a phase 3 registration study to investigate the efficacy and safety of OCS-05 for treatment of ON.
NEURITIS - PR-5301 – PIONEER-1
Principal Investigator: Padmaja Sudhakar, MD
Coordinator: James Lewis, james.lewis9888@uky.edu, 859-218-2231
Status: Open September 2026
Title: A Randomized, Double-Masked, Placebo-Controlled Study Assessing The Efficacy And Safety Of Privosegtor (Ocs-05) In Patients With Optic Neuritis (ON)
Study Objective: The Pioneer-1 study is a phase 3 registration study to investigate the efficacy and safety of OCS-05 for treatment of ON.
NEUROPATHY – NGF-NAION-301
Principal Investigator: Padmaja Sudhakar, MD
Coordinator: James Lewis, james.lewis9888@uky.edu, 859-218-2231
Status: Open September 2026
Title: Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Study Objective: The NAION study is a phase 3 study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION.
NEUROPATHY – NGF-NAION-301
Principal Investigator: Padmaja Sudhakar, MD
Coordinator: James Lewis, james.lewis9888@uky.edu, 859-218-2231
Status: Open September 2026
Title: Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Study Objective: The NAION study is a phase 3 study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION.
Parkinson's Disease
NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: New
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease
NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: New
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson's Disease
Investigate the Pharmacokinetics of Entacapone, Carbidopa, and Levodopa (Lecigon ®) Versus Carbidopa and Levodopa Enteral Suspension (Duodopa®/Duopa®)
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: New
Title: A Pharmacokinetic Study of Lecigon Enteral Suspension in Subjects With Advanced Parkinson's Disease: A Randomized, Cross-Over Study to Investigate the Pharmacokinetics of Entacapone, Carbidopa, and Levodopa (Lecigon ®) Versus Carbidopa and Levodopa Enteral Suspension (Duodopa®/Duopa®), Administered With and Without the Presence of Entacapone Orally Administered as Comtan®
Investigate the Pharmacokinetics of Entacapone, Carbidopa, and Levodopa (Lecigon ®) Versus Carbidopa and Levodopa Enteral Suspension (Duodopa®/Duopa®)
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: New
Title: A Pharmacokinetic Study of Lecigon Enteral Suspension in Subjects With Advanced Parkinson's Disease: A Randomized, Cross-Over Study to Investigate the Pharmacokinetics of Entacapone, Carbidopa, and Levodopa (Lecigon ®) Versus Carbidopa and Levodopa Enteral Suspension (Duodopa®/Duopa®), Administered With and Without the Presence of Entacapone Orally Administered as Comtan®
Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson's Disease
Principal Investigator: Zain Guduru, MD
Coordinator: Corisa Logan, RN
Status: Closed to enrollment
Title: A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson's Disease
Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson's Disease
Principal Investigator: Zain Guduru, MD
Coordinator: Corisa Logan, RN
Status: Closed to enrollment
Title: A 17-week, Phase 2, Randomized, Double-blind, Placebo-controlled, Flexible-dosing, Parallel-group, Multicenter Study of the Efficacy and Safety of Suvecaltamide in the Treatment of Moderate to Severe Residual Tremor in Participants with Parkinson's Disease
BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
Principal Investigator: Tritia Yamasaki, MD
Coordinator: Corisa Logan, RN
Status: Closed to enrollment
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
Principal Investigator: Tritia Yamasaki, MD
Coordinator: Corisa Logan, RN
Status: Closed to enrollment
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson's Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
UCB0599 in study participants with early Parkinson's disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Closed to Enrollment
Title: A double-blind, placebo-controlled, randomized, 18 month Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral UCB0599 in study participants with early Parkinson's disease
UCB0599 in study participants with early Parkinson's disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Closed to Enrollment
Title: A double-blind, placebo-controlled, randomized, 18 month Phase 2a study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral UCB0599 in study participants with early Parkinson's disease
UCB0599 in study participants with early Parkinson's disease (long-term)
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Closed to Enrollment
Title: A dose-blinded extension study to evaluate the long-term efficacy, safety, and tolerability of minzasolmin (UCB0599) in study participants with Parkinson's disease
UCB0599 in study participants with early Parkinson's disease (long-term)
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Closed to Enrollment
Title: A dose-blinded extension study to evaluate the long-term efficacy, safety, and tolerability of minzasolmin (UCB0599) in study participants with Parkinson's disease
ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson s disease experiencing motor fluctuations
Principal Investigator: John Slevin, MD
Coordinator: Michael Nsoesie
Status: Closed to Enrollment
Title: A multicenter, randomized, active-controlled, double-blind, doubledummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson s disease experiencing motor fluctuations (BouNDless)
ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson s disease experiencing motor fluctuations
Principal Investigator: John Slevin, MD
Coordinator: Michael Nsoesie
Status: Closed to Enrollment
Title: A multicenter, randomized, active-controlled, double-blind, doubledummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson s disease experiencing motor fluctuations (BouNDless)
PD GENEration Genetic Registry
Principal Investigator: Tritia Yamasaki, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: PD GENEration Genetic Registry
PD GENEration Genetic Registry
Principal Investigator: Tritia Yamasaki, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: PD GENEration Genetic Registry
CVN424 in Early Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Corisa Logan, RN
Status: Open to Enrollment
Title: A Randomized, Double-Blind, Placebo-Controlled Trial of CVN424 in Early Parkinson's Disease
CVN424 in Early Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Corisa Logan, RN
Status: Open to Enrollment
Title: A Randomized, Double-Blind, Placebo-Controlled Trial of CVN424 in Early Parkinson's Disease
CVN424 in Parkinson's Disease Patients with Motor Complications
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients with Motor Complications
CVN424 in Parkinson's Disease Patients with Motor Complications
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson's Disease Patients with Motor Complications
UCB0022 in Study Participants with Advanced Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: A Phase 2 Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants with Advanced Parkinson's Disease
UCB0022 in Study Participants with Advanced Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: A Phase 2 Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants with Advanced Parkinson's Disease
AMX0035 in Progressive Supranuclear Palsy (ORION)
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: A Phase 3 Study of Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)
AMX0035 in Progressive Supranuclear Palsy (ORION)
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: A Phase 3 Study of Safety and Efficacy of AMX0035 in Progressive Supranuclear Palsy (ORION)
Stereotactic Intracranial Implantation DSP-1083 into Subjects with Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses following Stereotactic Intracranial Implantation of DSP-1083 into Subjects with Parkinson's Disease
Stereotactic Intracranial Implantation DSP-1083 into Subjects with Parkinson's Disease
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Open to enrollment
Title: A Multicenter, Sham-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Clinical Responses following Stereotactic Intracranial Implantation of DSP-1083 into Subjects with Parkinson's Disease
Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls
Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls
Principal Investigator: John Slevin, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of Falls
Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 Trial)
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 Trial)
Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 Trial)
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 Trial)
Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levopoda-Treated Adults with Motor Flunctuations (TEMPO-3 Trial)
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levopoda-Treated Adults with Motor Flunctuations (TEMPO-3 Trial)
Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levopoda-Treated Adults with Motor Flunctuations (TEMPO-3 Trial)
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levopoda-Treated Adults with Motor Flunctuations (TEMPO-3 Trial)
58-Week Open-Label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: 58-Week Open-Label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
58-Week Open-Label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: 58-Week Open-Label Trial of Tavapadon in Parkinson's Disease (TEMPO-4 Trial)
Mesdopetam on Daily On-time Without Troublesome Dyskinesia in Patients with Parkinson's Disease
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily On-time Without Troublesome Dyskinesia in Patients with Parkinson's Disease
Mesdopetam on Daily On-time Without Troublesome Dyskinesia in Patients with Parkinson's Disease
Principal Investigator: Zain Guduru, MD
Coordinator: Renee Wagner, RN
Status: Closed
Title: Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily On-time Without Troublesome Dyskinesia in Patients with Parkinson's Disease
Pediatric Migraine
Rimegepant for the Treatment of Migraine (with or without aura) in Children and Adolescents >= 6 to <18 Years of Age
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Closed
Title: Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (with or without aura) in Children and Adolescents >= 6 to <18 Years of Age.
Rimegepant for the Treatment of Migraine (with or without aura) in Children and Adolescents >= 6 to <18 Years of Age
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Closed
Title: Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (with or without aura) in Children and Adolescents >= 6 to <18 Years of Age.
Rimegepant for the Treatment of Migraine (with or without aura) in Children and Adolescents >/= 6 to <18 years of age
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Closed
Title: Phase 3, multicenter, open-label study to assess the long-term safety and tolerability of rimegepant for the acute treatment of migraine (with or without aura) in children and adolescents >/= 6 to <18 years of age
Rimegepant for the Treatment of Migraine (with or without aura) in Children and Adolescents >/= 6 to <18 years of age
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Closed
Title: Phase 3, multicenter, open-label study to assess the long-term safety and tolerability of rimegepant for the acute treatment of migraine (with or without aura) in children and adolescents >/= 6 to <18 years of age
Lasmiditan for acute treatment of migraine: PIONEER-PEDS1 Study.
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: Pediatric Options for Migraine Relief: A randomized, double-blind, placebo-controlled study of lasmiditan for acute treatment of migraine: PIONEER-PEDS1 Study.
Lasmiditan for acute treatment of migraine: PIONEER-PEDS1 Study.
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: Pediatric Options for Migraine Relief: A randomized, double-blind, placebo-controlled study of lasmiditan for acute treatment of migraine: PIONEER-PEDS1 Study.
Lasmiditan in Pediatric Patients with Migraine PIONEER-PED2
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine PIONEER-PED2
Lasmiditan in Pediatric Patients with Migraine PIONEER-PED2
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine PIONEER-PED2
Eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: 19356A (PROSPECT-2): Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine
Eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: 19356A (PROSPECT-2): Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17 years) for the preventive treatment of chronic migraine
Intravenous (IV) eptinezumab in paediatric patients (6 to 17 years) for the preventive treatment of episodic migraine
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: 19356A (PROSPECT-2): Interventional, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of intravenous (IV) eptinezumab in paediatric patients (6 to 17 years) for the preventive treatment of episodic migraine
Intravenous (IV) eptinezumab in paediatric patients (6 to 17 years) for the preventive treatment of episodic migraine
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to Enrollment
Title: 19356A (PROSPECT-2): Interventional, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of intravenous (IV) eptinezumab in paediatric patients (6 to 17 years) for the preventive treatment of episodic migraine
Eptinezumab in children and adolescents with chronic or episodic migraine
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to enrollment
Title: Long-term, open-label (dose-blinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine.
Eptinezumab in children and adolescents with chronic or episodic migraine
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Kiel Butterfield
Status: Open to enrollment
Title: Long-term, open-label (dose-blinded), extension study of eptinezumab in children and adolescents with chronic or episodic migraine.
Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: Open to enrollment
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: Open to enrollment
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine-the REBUILD-2 Study
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: Open to enrollment
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine-the REBUILD-2 Study
Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine-the REBUILD-2 Study
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: Open to enrollment
Title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age with Chronic Migraine-the REBUILD-2 Study
Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: New
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: New
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17) (Long Term Safety)
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: New
Title: A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17) (Long Term Safety)
Principal Investigator: Sharoon Qaiser, MD
Coordinator: Matt Taylor
Status: New
Title: A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Sleep
Biofluid Markers in REM behavior
Principal Investigator: Daniel Lee MD/Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Open to enrollment
Title: Predicting the Development of Neurodegenerative disorders through saliva biomarkers in patients with REM sleep behavior disorder.
Description: Patients with a diagnosis of REM sleep behavior disorder are tested at a baseline visit and approximate 1 year research visit to try to determine markers in blood, or saliva that help predict conversion to Parkinson's disease or other neurodegenerative conditions.
Biofluid Markers in REM behavior
Principal Investigator: Daniel Lee MD/Tritia Yamasaki MD PhD
Coordinator: Corisa Logan
Status: Open to enrollment
Title: Predicting the Development of Neurodegenerative disorders through saliva biomarkers in patients with REM sleep behavior disorder.
Description: Patients with a diagnosis of REM sleep behavior disorder are tested at a baseline visit and approximate 1 year research visit to try to determine markers in blood, or saliva that help predict conversion to Parkinson's disease or other neurodegenerative conditions.
RELIANCE: The Syn-Sleep Study
Principal Investigator: Daniel Lee MD
Coordinator: Matt Taylor
Status: Open to enrollment
Description: This is a multicenter study of patients with REM behavior disorder to determine if skin biopsy testing has good sensitivity and specificity in the disease and whether it can help predict conversion to Parkinson's disease or other neurologic diseases. This study involves 1 research visit per year for 3 years with skin tests and research testing at each visit.
RELIANCE: The Syn-Sleep Study
Principal Investigator: Daniel Lee MD
Coordinator: Matt Taylor
Status: Open to enrollment
Description: This is a multicenter study of patients with REM behavior disorder to determine if skin biopsy testing has good sensitivity and specificity in the disease and whether it can help predict conversion to Parkinson's disease or other neurologic diseases. This study involves 1 research visit per year for 3 years with skin tests and research testing at each visit.
Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
Principal Investigator: Meriem Daniel Lee, MD
Coordinator: Matt Taylor
Status: Open to enrollment
Title: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
Principal Investigator: Meriem Daniel Lee, MD
Coordinator: Matt Taylor
Status: Open to enrollment
Title: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies
Spinal Muscular Atrophy
Long Term Follow-Up Study of Patients with Spinal Muscular Atrophy receiving Risdiplam Treatment
Principal Investigator: David Toupin, MD
Coordinator: Laura Goins
Status: Open to enrollment
Title: Long Term Follow-Up Study of Patients with Spinal Muscular Atrophy receiving Risdiplam Treatment
Long Term Follow-Up Study of Patients with Spinal Muscular Atrophy receiving Risdiplam Treatment
Principal Investigator: David Toupin, MD
Coordinator: Laura Goins
Status: Open to enrollment
Title: Long Term Follow-Up Study of Patients with Spinal Muscular Atrophy receiving Risdiplam Treatment
Stroke
Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Principal Investigator: Jessica Lee, MD
Coordinator: Lynn Cagle, RN
Status: Open to enrollment
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Principal Investigator: Jessica Lee, MD
Coordinator: Lynn Cagle, RN
Status: Open to enrollment
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack
Statins Use in Intracerebral Hemorrhage Patients (SATURN)
Principal Investigator: Kevin O'Connor, MD
Coordinator: Lynn Cagle, RN
Status: Open to enrollment
Title: Statins Use in Intracerebral Hemorrhage Patients (SATURN)
Statins Use in Intracerebral Hemorrhage Patients (SATURN)
Principal Investigator: Kevin O'Connor, MD
Coordinator: Lynn Cagle, RN
Status: Open to enrollment
Title: Statins Use in Intracerebral Hemorrhage Patients (SATURN)
Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)
Principal Investigator: Suhas Gangadhara, MD
Coordinator: Lynn Cagle, RN
Status: Open to enrollment
Title: Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)
Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)
Principal Investigator: Suhas Gangadhara, MD
Coordinator: Lynn Cagle, RN
Status: Open to enrollment
Title: Anticoagulation in ICH Survivors for Prevention and Recovery (ASPIRE)
SATURN
Principal Investigator: Kevin O’Connor, MD
Coordinator: Lynne Cagle lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: Saturn Statins Use In Intracerebral Hemorrhage Patients
Study Objective: A multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE)clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation (restarting) of statin therapy (using the same agent and dose that they were using at ICH onset). Randomization will take into account: clinical site, statin dose and indication (primary vs. secondary prevention), current use or intent-to-use oral anticoagulants (OAC) and/or antiplatelets in the long-term post-ICH, and severity of ICH upon presentation as assessed by baseline ICH volume.
SATURN
Principal Investigator: Kevin O’Connor, MD
Coordinator: Lynne Cagle lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: Saturn Statins Use In Intracerebral Hemorrhage Patients
Study Objective: A multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE)clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation (restarting) of statin therapy (using the same agent and dose that they were using at ICH onset). Randomization will take into account: clinical site, statin dose and indication (primary vs. secondary prevention), current use or intent-to-use oral anticoagulants (OAC) and/or antiplatelets in the long-term post-ICH, and severity of ICH upon presentation as assessed by baseline ICH volume.
ASPIRE
Principal Investigator: Suhas Gangadhara, MD
Coordinator: Lynne Cagle lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: ASPIRE The Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke Prevention and Recovery
Study Objective: ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH. A total of 700 patients, age 18 years or older, with an ICH 14-180 days before entry will be randomized in a 1:1 ratio to receive apixaban (5 mg tablets twice daily, or 2.5 mg tablets twice daily for patients meeting standard dose-adjustment requirements) or aspirin (81 mg tablet once daily).
ASPIRE
Principal Investigator: Suhas Gangadhara, MD
Coordinator: Lynne Cagle lynne.cagle@uky.edu, 859-218-5443
Status: Open to enrollment
Title: ASPIRE The Anticoagulation in Intracerebral Hemorrhage Survivors for Stroke Prevention and Recovery
Study Objective: ASPIRE is a randomized, double-blinded, phase III clinical trial designed to test the efficacy and safety of anticoagulation, compared with aspirin, in patients with a recent ICH. A total of 700 patients, age 18 years or older, with an ICH 14-180 days before entry will be randomized in a 1:1 ratio to receive apixaban (5 mg tablets twice daily, or 2.5 mg tablets twice daily for patients meeting standard dose-adjustment requirements) or aspirin (81 mg tablet once daily).