Principal Investigator:  Edward Kasarskis, MD, PhD

Coordinator:  Ryan Blood

Status:  Open to enrollment

TITLE:  A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTER STUDY WITH AN OPEN-LABEL EXTENSION TO EVALUATE THE EFFICACY AND SAFETY OF RAVULIZUMAB IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS)

STUDY OBJECTIVE:  The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

https://clinicaltrials.gov/ct2/show/NCT04248465

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.

https://clinicaltrials.gov/ct2/show/NCT04297683

Principal Investigator:  Edward Kasarskis, MD, PhD

Coordinator:  Ryan Blood

Status:  Open to enrollment

TITLE:  THERAPY IN AMYOTROPHIC LATERAL SCLEROSIS (TAME)

STUDY OBJECTIVE:  The purpose of this study is to determine if memantine at 20 mg BID when used in conjunction with riluzole, can slow down the disease progression of patients with ALS including potentially improving their neuropsychiatric changes, as well as determine if serum biomarkers can be used both as a diagnostic and a prognostic marker in patients with ALS.

https://clinicaltrials.gov/ct2/show/NCT02118727

Principal Investigator:  Edward Kasarskis, MD, PhD

Coordinator:  Ryan Blood

Status:  Enrolling by invitation

TITLE:  REGIMEN A WILL EVALUATE THE SAFETY AND EFFICACY OF A SINGLE STUDY DRUG, ZILUCOPLAN, IN PARTICIPANTS WITH ALS.

STUDY OBJECTIVE:  If a participant is randomized to Regimen A - Zilucoplan, the participant will complete a screening visit to assess additional Regimen A eligibility criteria. Once Regimen A eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active zilucoplan or matching placebo.

https://clinicaltrials.gov/ct2/show/NCT04436497

Principal Investigator:  Edward Kasarskis, MD, PhD

Coordinator:  Ryan Blood

Status:  Enrolling by invitation

TITLE:  HEALEY ALS PLATFORM TRIAL - REGIMEN B VERDIPERSTAT

STUDY OBJECTIVE:  If a participant is randomized to Regimen B - Verdiperstat, the participant will complete a screening visit to assess additional Regimen B eligibility criteria. Once Regimen B eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active Verdiperstat or matching placebo.

https://clinicaltrials.gov/ct2/show/NCT04436510

Principal Investigator:  Edward Kasarskis, MD, PhD

Coordinator:  Ryan Blood

Status:  Enrolling by invitation

TITLE:  HEALEY ALS PLATFORM TRIAL - REGIMEN C CNM-AU8

STUDY OBJECTIVE:  If a participant is randomized to Regimen C - CNM-Au8, the participant will complete a screening visit to assess additional Regimen C eligibility criteria. Once Regimen C eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active CNM-Au8 or matching placebo.

https://clinicaltrials.gov/ct2/show/NCT04414345

Principal Investigator:  Edward Kasarskis, MD, PhD

Coordinator:  Ryan Blood

Status:  Enrolling by invitation

TITLE:  HEALEY ALS PLATFORM TRIAL - REGIMEN D PRIDOPIDINE

STUDY OBJECTIVE:  If a participant is randomized to Regimen D Pridopidine, the participant will complete a screening visit to assess additional Regimen D eligibility criteria. Once Regimen D eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active pridopidine or matching placebo.

https://clinicaltrials.gov/ct2/show/NCT04615923

Principal Investigator:  Edward Kasarskis, MD, PhD

Coordinator:  Ryan Blood

Status:  Closed to enrollment

TITLE:  EFFECTS OF ORAL LEVOSIMENDAN (ODM-109) ON RESPIRATORY FUNCTION IN PATIENTS WITH ALS: OPEN-LABEL EXTENSION FOR PATIENTS COMPLETING STUDY 3119002

STUDY OBJECTIVE:  The primary objective, in addition to continuing treatment for subjects in REFALS study, is to evaluate long-term safety of oral levosimendan in amyotrophic lateral sclerosis (ALS) patients.

https://clinicaltrials.gov/ct2/show/NCT03948178

Principal Investigator:  Meriem Bensalem-Owen, MD

Coordinator:  Pat Arnold

Status:  Open 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.

Principal Investigator:  Sally Mathis, 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).

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.

Principal Investigator:  Meriem Bensalem-Owen, MD

Coordinator:  Dawn Baker

Status:  Closed to enrollment

TITLE:  AN OPEN‑LABEL, MULTICENTER, EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PADSEVONIL AS ADJUNCTIVE TREATMENT OF FOCAL-ONSET SEIZURES IN ADULT SUBJECTS WITH DRUG-RESISTANT EPILEPSY (PHASE 2/3 STUDY)

STUDY OBJECTIVE:  Primary Objective: to evaluate the long-term safety and tolerability of PSL administered at individualized doses between 100mg/day and 800mg/day as adjunctive treatment for subjects with focal-onset seizures and drug-resistant epilepsy.

https://clinicaltrials.gov/ct2/show/NCT03370120

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.

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

Principal Investigator:  Tritia Yamasaki, MD, PhD

Coordinator:  Amanda Wilburn

Status:  Open to enrollment

TITLE:  NEUROBANK

STUDY OBJECTIVE:  The NeuroBank collects a variety of biospecimens from subjects being evaluated and treated for neurologic conditions at the University of Kentucky Albert B. Chandler Hospital and the Kentucky Neuroscience Institute.

Principal Investigator:  Siddharth Kapoor, MD

Coordinator:  Dawn Baker

Status:  Open to enrollment

TITLE:  RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ERENUMAB IN ADULTS WITH CHRONIC MIGRAINE AND MEDICATION OVERUSE HEADACHE. ( PHASE 3B STUDY)

STUDY OBJECTIVE:  To evaluate the effect of erenumab compared with placebo on achieving medication overuse headache (MOH) remission during the double-blind treatment period (DBTP)

https://clinicaltrials.gov/ct2/show/NCT03971071

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

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.

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

Principal Investigator:  Zain Guduru, MD

Coordinator:  Renee Wagner

Status:  Open to enrollment

TITLE:  FIXED-DOSE TRIAL IN EARLY PARKINSON'S DISEASE (PD) (TEMPO-1)

STUDY OBJECTIVE:  The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.

https://clinicaltrials.gov/ct2/show/NCT04201093

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

Principal Investigator:  Zain Guduru, MD

Coordinator:  Renee Wagner

Status:  Open to enrollment

Principal Investigator:  Zain Guduru, MD

Coordinator:  Renee Wagner

Status:  Open to enrollment

TITLE:  A PHASE 3, TWELVE-WEEK, MULTI-CENTER, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF P2B001 ONCE DAILY COMPARED TO ITS INDIVIDUAL COMPONENTS IN SUBJECTS WITH EARLY PARKINSO

STUDY OBJECTIVE:  To determine the superiority of P2B001 0.6/0.75 mg as compared to its individual components in the change of total UPDRS score (defined as sum of parts II and III, scores (0-160).

https://clinicaltrials.gov/ct2/show/NCT03329508

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.

Principal Investigator:  Zain Guduru, MD

Coordinator:  Morgan Yazell

Status:  Open to enrollment

TITLE:  REGISTRY FOR THE ADVANCEMENT OF DBS IN PARKINSON’S DISEASE

Principal Investigator:  Zain Guduru, MD

Coordinator:  Michael Nsoesie / Renee Wagner

Status:  Open to enrollment

TITLE:  FIXED DOSE TRIAL IN EARLY PARKINSON’S DISEASE – DOUBLE-BLIND, RANDOMIZED PLACEBO CONTROLLED, PARALLEL-GROUP, 27-WEEK STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PD PATIENTS.  OPEN LABEL EXTENSION STUDY

STUDY OBJECTIVE:  To assess the efficacy of 2 fixed doses of tavapadon in subjects with early PD.

https://clinicaltrials.gov/ct2/show/NCT04201093

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.

https://clinicaltrials.gov/ct2/show/NCT03924414

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.

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.

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.

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.

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  ATRIAL CARDIOPATHY AND ANTITHROMBOTIC DRUGS IN PREVENTION AFTER CRYPTOGENIC STROKE (ARCADIA) - APIXABAN VS. ASPIRIN FOR PREVENTION OF ACUTE ISCHEMIC STROKE IN SUBJECTS WITH POST- ACUTE ISCHEMIC STROKE.

STUDY OBJECTIVE:  To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

https://clinicaltrials.gov/ct2/show/NCT03192215

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  ARCADIA-CSI (COGNITION AND SILENT INFARCTS) –ASSESS SILENT INFARCTS WITH RATE OF COGNITIVE DECLINE.

STUDY OBJECTIVE:  To complement the ARCADIA trial, we have designed ARCADIA-CSI, an ancillary study in which we will assess Cognitive function and Silent Infarcts in a subset of the ARCADIA population. The scientific premise of our proposal is that silent brain infarcts are an important cause of post-stroke cognitive decline and that anticoagulation with apixaban (compared to aspirin) will reduce both silent infarcts and the rate of cognitive decline in patients with stroke of unknown cause and atrial cardiopathy.

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  ANTICOAGULATION IN INTRACEREBRAL HEMORRHAGE (ICH) SURVIVORS FOR STROKE PREVENTION AND RECOVERY - ANTICOAGULATION IN ACUTE ISCHEMIC STROKE SURVIVORS FOR STROKE PREVENTION.

STUDY OBJECTIVE:  To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and AF.

https://clinicaltrials.gov/ct2/show/NCT03907046

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR ASYMPTOMATIC CAROTID STENOSIS TRIAL (CREST-2) - CAROTID STENOSIS-MEDICAL MANAGEMENT WITH ENDARECTOMY OR STENT

STUDY OBJECTIVE:  There are two equally important primary hypotheses, which will be tested in two independent, paralleled, randomized clinical trials. One trial will test the primary hypothesis that intensive medical management differs from the combination of CEA and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis. One trial will test the primary hypothesis that intensive medical management differs from the combination of CAS and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.

https://clinicaltrials.gov/ct2/show/NCT02089217

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  A PHASE IIA, DOUBLE-BLIND, SINGLE DOSE, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND POTENTIAL EFFICACY OF LT3001 DRUG PRODUCT IN SUBJECTS WITH ACUTE ISCHEMIC STROKE (AIS).

STUDY OBJECTIVE:  To determine the safety of a single dose (0.025 mg/kg) of LT3001 drug product administered intravenously (IV) in subjects with acute ischemic stroke (AIS).

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  MULTI-ARM OPTIMIZATION OF STROKE THROMBOLYSIS (MOST): A SINGLE BLINDED, RANDOMIZED CONTROLLED ADAPTIVE, MULTI-ARM, ADJUNCTIVE-THROMBOLYSIS EFFICACY TRIAL IN ISCHEMIC STROKE - INVESTIGATIONAL STUDY DRUG POST-INTRACEREBRAL HEMORRHAGE.

STUDY OBJECTIVE:  The primary efficacy objective of the MOST trial is to determine if argatroban (100 microgram/kg bolus followed by 3microgram/kg per minute for 12 hours) or eptifibatide (135microgram/kg bolus followed by 0.75microgram/kg/min infusion for two hours) results in improved 90-day modified Rankin scores (mRS) as compared with placebo in acute ischemic stroke (AIS) patients treated with 0.9mg/kg IV rt -PA within three hours of symptom onset. Patients may also receive endovascular thrombectomy (ET) per usual care. Time of onset is defined as the last time the patient was last known to be well.

https://clinicaltrials.gov/ct2/show/NCT03735979

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  SLEEP FOR STROKE MANAGEMENT AND RECOVERY TRIAL - OBSTRUCTIVE SLEEP APNEA POST-ACUTE ISCHEMIC STROKE.

STUDY OBJECTIVE:  The primary goals of this study are to determine whether treatment of OSA with positive airway pressure starting shortly after acute ischemic stroke or high-risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

https://clinicaltrials.gov/ct2/show/NCT03812653

Principal Investigator:  L. Creed Pettigrew, MD

Coordinator:  Pat Arnold

Status:  Open to enrollment

TITLE:  SUBJECTS TAKING STATINS PRIOR TO ACUTE ISCHEMIC STROKE AND POST-STROKE.

STUDY OBJECTIVE: 

https://clinicaltrials.gov/ct2/show/NCT03936361

Principal Investigator:  Jay 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

Principal Investigator:  Jay 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.

Principal Investigator:  Jay Avasarala, MD

Coordinator:  Amanda Wilburn

Status:  Open to enrollment

TITLE:  USING FUNDUS PHOTOGRAPHY TO LOOK AT DISEASE STATE IN MS PATIENTS.

Principal Investigator:  Jay Avasarala, MD

Coordinator:  Amanda Wilburn

Status:  Open to enrollment

TITLE:  RELAPSING FORMS OF MULTIPLE SCLEROSIS (RMS) STUDY OF BRUTON'S TYROSINE KINASE (BTK) INHIBITOR SAR442168 (GEMINI 2)

STUDY OBJECTIVE:  To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS

https://clinicaltrials.gov/ct2/show/NCT04410991

Principal Investigator:  Jay 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.

Principal Investigator:  Jay Avasarala, MD

Coordinator:  Amanda Wilburn

Status:  Open to enrollment

TITLE:  PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS (PPMS) STUDY OF BRUTON'S TYROSINE KINASE (BTK) INHIBITOR SAR442168 (PERSEUS)

STUDY OBJECTIVE:  To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS)

https://clinicaltrials.gov/ct2/show/NCT04458051

Principal Investigator:  Jay 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).

Principal Investigator:  Zabeen Mahuwala, MD

Coordinator:  Dawn Baker

Status:  Open to enrollment

TITLE:  RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING EFFICACY AND SAFETY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS (PHASE 3 STUDY)

STUDY OBJECTIVE:  To demonstrate the clinical efficacy of rozanolixizumab in patients with generalized MG.

https://clinicaltrials.gov/ct2/show/NCT03971422

Principal Investigator:  Zabeen Mahuwala, MD

Coordinator:  Dawn Baker

Status:  Open to enrollment

TITLE:  A RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF ROZANOLIXIZUMAB IN ADULT PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS (PHASE 3 STUDY)

STUDY OBJECTIVE:  To evaluate the long-term safety and tolerability of rozanolixizumab in study participants with generalized MG.

https://clinicaltrials.gov/ct2/show/NCT04124965

Principal Investigator:  Zabeen Mahuwala, MD

Coordinator:  Amanda Wilburn

Status:  Open to enrollment

TITLE:  A STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF ROZANOLIXIZUMAB IN SUBJECTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (MYCIDPCHOICE)

STUDY OBJECTIVE:  The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).

https://clinicaltrials.gov/ct2/show/NCT03861481