Closed Clinical Studies

Principal Investigator: Meriem Bensalem-Owen, M.D. 

Coordinator: James Lewis 

Status: Closed 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 

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 adult subjects ≥18 years of age from different geographic regions, diagnosed with focal epilepsy, and taking 1 to 3 ASMs. 

https://clinicaltrials.gov/study/NCT03796962?cond=Focal%20Epilepsy&spons=Xenon%20Pharmaceuticals%20Inc.&rank=1    

Principal Investigator: Sharoon Qaiser, MD 

Coordinator: Matt Taylor 

Status: Closed 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 

Study Objective: This study evaluates 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. 

https://clinicaltrials.gov/study/NCT03432286 

Principal Investigator: Sharoon Qaiser, MD 

Coordinator: Matt Taylor 

Status: Closed 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 

Study Objective: This study evaluates 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. 

https://clinicaltrials.gov/study/NCT04616326 

Principal Investigator: Sharoon Qaiser, MD 

Coordinator: Matt Taylor, matt.taylor@uky.edu, 502-961-6047 

Status: Closed to enrollment 

Title: 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 

Study Objective: The goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants. 

https://clinicaltrials.gov/study/NCT05897320 

Principal Investigator: Sharoon Qaiser, MD 

Coordinator: Matt Taylor 

Status: Closed to enrollment 

Title: 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 

Study Objective: To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in participants ages 12 to 17 with chronic migraine. 

https://clinicaltrials.gov/study/NCT04965675 

Principal Investigator: Sharoon Qaiser, MD 

Coordinator: Matt Taylor 

Status: Closed to enrollment 

Title: Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine 

Study Objective: To assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine. 

https://clinicaltrials.gov/study/NCT05164172 

Principal Investigator:  John Slevin, MD 

Coordinator:  Renee Wagner 

Status:  Closed 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 WithParkinson’s Disease 

Study Objective:  The objective of the study is to determine the effect of ND0612 on daily ON time without troublesome dyskinesia (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 participants with Parkinson’s disease experiencing motor fluctuations. 

https://clinicaltrials.gov/ct2/show/NCT04006210 

Principal Investigator: Tritia Yamasaki MD PhD 

Coordinator:  Corisa Logan, corisa.logan@uky.edu, 859-218-5076 

Status:  Closed to enrollment 

Title: A Phase 2, Randomized, Double-Blind, PlaceboControlled 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 

Description: This study assesses the efficacy of BIA 28-6156 in delaying motor progression in subjects with Parkinson’s disease carrying a GBA1 gene mutation, as measured by the MDS-UPDRS. 

Principal Investigator:  John Slevin, MD 

Coordinator:  Corisa Logan, corisa.logan@uky.edu, 859-218-5076 

Status:  Closed to enrollment 

Title:  Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Study of CVN424 in Parkinson’s Disease Patients with Motor Complication 

Study Objective:  To assess the efficacy of CVN4234 dosed once daily, compared to placebo for change in OFF time in Parkinson’s disease.  To further assess the effect of CVN424 on Parkinson’s disease motor features (complete motor diary profile, MDS-UPDRS scores).   Looking at change from Baseline to Week 12 in average daily OFF time.   

https://clinicaltrials.gov/study/NCT06553027?term=CVN424&rank=4 

Principal Investigator: Craig van Horne, MD PhD 

Coordinator: Jaimie Hixson – Jaimie.henderson@uky.edu 859-323-1908 

Status: Closed to enrollment. Study visits are ongoing 

Title: Feasibility and safety of autoloGous UncondItioneD pEripheral nerve tissue delivery to the substantia nigra (GUIDE) 

Study Objective: To evaluate the safety and feasibility of implanting unconditioned PNT to the substantia nigra at the time of DBS surgery. Clinical changes in PD symptoms and sural nerve regeneration after sural nerve biopsy will be monitored post-operatively.  

https://clinicaltrials.gov/study/NCT05377281?locStr=Kentucky&country=United%20States&state=Kentucky&cond=Parkinsons%20Disease&term=van%20Horne&intr=surgery&rank=3 

Principal Investigator: Craig van Horne, MD PhD 

Coordinator: Jaimie Hixson – Jaimie.henderson@uky.edu 859-323-1908 

Status: Closed to enrollment. Study visits are ongoing 

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 

Study Objective: Assess the feasibility and safety of the combined peripheral nerve graft/DBS surgical procedure and the long term clinical safety of the peripheral nerve implant.  

https://clinicaltrials.gov/study/NCT02369003?locStr=Kentucky&country=United%20States&state=Kentucky&cond=Parkinsons%20Disease&term=van%20Horne&intr=surgery&rank=4 

Principal Investigator: Zabeen Mahuwala MD PhD 

Coordinator:  Corisa Logan, corisa.logan@uky.edu, 859-218-5076 

Status:  closed 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) 

Study Objective: The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG.  

https://clinicaltrials.gov/study/NCT05403541 

Principal Investigator: Ima Ebong MD PhD 

Coordinator:  Corisa Logan, corisa.logan@uky.edu, 859-218-5076 

Status:  closed to enrollment 

Title: The ME&MG Digital Solution for Autonomous Assessment of Myasthenia Gravis: a Validation Study 

Study Objective: The objectives are to validate the accuracy, reliability and reproducibility of the unsupervised at-home self-assessment of symptoms on the patient's smartphone with the ME&MG app versus the standard in-clinic testing, as well as to evaluate the safety of the solution, its usability and satisfaction. ME&MG is a standalone software intended to be used as an unsupervised digital self-assessment tool for the monitoring of disabilities in patients living with MG.  

Principal Investigator: Zabeen Mahuwala MD 

Coordinator:  Corisa Logan, corisa.logan@uky.edu, 859-218-5076 

Status:  Closed to Enrollment 

Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG) 

Objective: The AURORA Study evaluates 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. 

Principal Investigator: Daniel Lee, MD 

Coordinator: Corisa Logan, corisa.logan@uky.edu@uky.edu, 859-218-5076 

Status: Closed to enrollment 

Title: Cutaneous Phosphorylated Alpha-Synuclein for Detection of Prodromal Synucleinopathies 

Study Objective: To evaluate the use of the Syn-One Test™ for identifying patients with idiopathic rapid eye movement sleep disorder (iRBD) that will progress to synucleinopathies, such as Parkinson’s disease, dementia with Lewy bodies, pure autonomic failure and multiple system atrophy. CND Life Sciences will address the following Specific Aims: 1) Advance the diagnostic utility of the Syn-One Test™ by defining the metrics of P-SYN deposition and nerve fiber degeneration that predict phenoconversion in iRBD patients, and 2) Enhance pathological reading through digital quantitative analysis of the Syn-One Test™ using an AI-augmented detection system.  

https://clinicaltrials.gov/study/NCT05757206 

Principal Investigator: Jessica Lee, MD 

Coordinator: Lynne Cagle lynne.cagle@uky.edu, 859-218-5443 

Status: Closed to enrollment 

Title: Librexia-Stroke 

Study Objective: 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