Current Clinical Studies

ALS

REFALS-ES

Principle Investigator: Edward Kasarskis, MD, PhD.

Coordinator: Ghadah Karasneh (ghadah.karasneh@uky.edu)

Open to enrollment

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

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

 

 

BIOBANK

 

NeuroBank

Principle Investigator: Tritia Yamasaki, MD, PhD.

Coordinator: Amanda Wilburn (amanda.wilburn@uky.edu)

Open to enrollment

COLLECTION OF BIOLOGICAL SPECIMENS FOR FUTURE NEUROSCIENCE RESEARCH- CAN COLLECT FROM NEUROLOGY AND NEUROSURGERY.

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.

 

 

EPILEPSY

 

Neuropace PAS

Principle Investigator: Meriem Bensalem-Owen, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

IMPLANTATION OF NEUROSTIMULATOR FOR REFRACTORY EPILEPSY IN SUBJECTS WHO FAILED ANTIEPILEPTIC DRUGS.

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.

 

YKP3089C025

Principle Investigator: Siddharth Kapoor, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Closed to enrollment

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)

To demonstrate the efficacy of adjunctive cenobamate 200 mg therapy compared with placebo on PGTC seizures.

 

YKP3089C033-1

Principle Investigator: Siddharth Kapoor, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Closed to enrollment

A MULTICENTER OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CENOBAMATE ADJUNCTIVE THERAPY IN SUBJECTS WITH PRIMARY GENERALIZED TONIC-CLONIC SEIZURE

To evaluate the safety and tolerability of cenobamate in subjects with PGTC seizures

 

E2007-G000-410

Principle Investigator: Sally Mathis, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Closed to enrollment

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 SEIZURES (PHASE 4 STUDY)

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

Principle Investigator: Meriem Bensalem-Owen, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Closed to enrollment

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)

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.

 

EP0093

Principle Investigator: Meriem Bensalem-Owen, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Closed to enrollment

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)

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

 

 

HEADACHE

 

Erenumab

Principle Investigator: Siddharth Kapoor, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Open to enrollment

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)

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

 

 

MOVEMENT DISORDER

 

APNG - Project IV

Principle Investigator: Craig van Horne, MD, PhD.

Coordinator: Morgan Yazell (morgan.yazell@uky.edu)

Open to enrollment

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

Principle Investigator: John Slevin, MD

Coordinator: Michael Nsoesie / Renee Wagner (michael.nsoesie@uky.edu; renee.wagner@uky.edu)

Open to enrollment

A MULTICENTER, 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 PARKINSON’S DISEASE EXPERIENCING MOTOR FLUCTUATIONS (BOUNDLESS).  SUBCUTANEOUS LEVODOPA (60MG/ML LD AND 7.5MG/ML CD). DOUBLE BLIND, DOUBLE-DUMMY, PARALLEL GROUP CLINICAL TRIAL COMPARING ND0612-317 TO ORAL IR-LD/CD IN SUBJECTS WITH PD EXPERIENCING MOTOR FLUCTUATIONS.  1 YEAR OPEN LABEL EXTENSION AVAILABLE TO THOSE THAT COMPLETE DOUBLE BLIND MAINTENANCE PERIOD.

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

 

DBS Eval

Principle Investigator: Craig van Horne, MD, PhD.

Coordinator: Morgan Yazell (morgan.yazell@uky.edu)

Open to enrollment

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 LEAST SIX MONTHS.

 

P2B001/003

Principle Investigator: Zain Guduru, MD

Coordinator: Renee Wagner (renee.wagner@uky.edu)

Open to enrollment

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 PARKINSON’S DISEASE AND TO A CALIBRATION ARM OF PRAMIPEXOLE ER.  – EARLY PD PATIENTS – RASAGILINE CONTROLLED RELEASE AND PRAMIPEXOLE  (TOGETHER IN ONE PILL) FIXED DOSE EXTENDED RELEASE – DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF P2B001 TAKEN ONCE A DAY AND COMPARED TO THE INDIVIDUAL COMPONENTS (PRAMIPEXOLE 0.6 MG, RASAGILINE 0.75MG AND CALIBRATION ARM OF PRAMIPEXOLE ER (1.5, 3.0 OR 4.5MG).  12 WEEK STUDY – 2 DOSAGE STRENGTHS OF COMBINATION PRODUCT – 0.6 MG PRAMIPEXOLE/0.75 MG RASAGILINE OR 0.3MG PRAMIPEXOLE/0.75MG RASAGILINE.  GOAL - CLINICAL EFFICACY WITH LOW RISK OF SIDE EFFECTS.

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

 

phMRI

Principle Investigator: Zain Guduru, MD

Coordinator: Morgan Yazell (morgan.yazell@uky.edu)

Open to enrollment

A PILOT STUDY TO EXAMINE APOMORPHINE-INDUCED BOLD ACTIVATION IN PATIENTS WITH PARKINSON’S DISEASE.

 

RAD-PD

Principle Investigator: Zain Guduru, MD

Coordinator: Morgan Yazell (morgan.yazell@uky.edu)

Open to enrollment

REGISTRY FOR THE ADVANCEMENT OF DBS IN PARKINSON’S DISEASE.  FOLLOW PATIENTS THAT ARE HAVING DBS PLACED AS STANDARD OF CARE.  MRI SCANS, QUESTIONNAIRES AND EXAM AT REGULARLY SCHEDULED DBS FOLLOW-UP VISITS.  QUESTIONNAIRES COMPLETED WHILE WAITING IN WAITING ROOM AND EXAM ROOM.  SOME QUESTIONNAIRES CAN BE COMPLETED AT HOME VIA SECURE WEBSITE.

 

TemPo - 1

Principle Investigator: Zain Guduru, MD

Coordinator: Michael Nsoesie / Renee Wagner (michael.nsoesie@uky.edu; renee.wagner@uky.edu)

Open to enrollment

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 AVAILABLE TO THOSE WHO COMPLETE THE DOUBLE-BLIND STUDY.

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

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

TOPAZ Study

Principle Investigator: John Slevin, MD

Coordinator: Renee Wagner (renee.wagner@uky.edu)

Open to enrollment

TOPAZ (TRIAL OF PARKINSON'S AND ZOLEDRONIC ACID).  REFERRAL SITE FOR STUDY.

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

Principle Investigator: Craig van Horne, MD, PhD.

Coordinator: Morgan Yazell (morgan.yazell@uky.edu)

Closed to enrollment

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

Principle Investigator: Craig van Horne, MD, PhD.

Coordinator: Morgan Yazell (morgan.yazell@uky.edu)

Closed to enrollment

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

Principle Investigator: Julie Gurwell, PhD, PA-C.

Coordinator: Morgan Yazell (morgan.yazell@uky.edu)

Closed to enrollment

EXPLORING DOPAMINE TRANSPORTER SINGLE-PHOTON EMISSION COMPUTED TOMOGRAPHY QUANTIFICATION AS A MEASURE OF DISEASE PROGRESSION IN IDIOPATHIC PARKINSON’S DISEASE.

 

 

MULTIPLE SCLEROSIS

 

Click-MS

Principle Investigator: Jay Avasarala, MD

Coordinator: Amanda Wilburn (amanda.wilburn@uky.edu)

Open to enrollment

CLADRIBINE TABLETS FOR RELAPSING MS PATIENTS WITH PREVIOUS SUBOPTIMAL RESPONSE TO INJECTABLE DISEASE MODIFYING THERAPIES.

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

Principle Investigator: Jay Avasarala, MD

Coordinator: Amanda Wilburn (amanda.wilburn@uky.edu)

Open to enrollment

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

Principle Investigator: Jay Avasarala, MD

Coordinator: Amanda Wilburn (amanda.wilburn@uky.edu)

Open to enrollment

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

 

MS and NMOSD in African American patients

Principle Investigator: Jay Avasarala, MD

Coordinator: Amanda Wilburn (amanda.wilburn@uky.edu)

Open to enrollment

DATA COLLECTION OF PATIENTS WITH MS AND/OR NMOSD AT KNI TO TRACK DISEASE PROGRESSION.

 

Retinal imaging in MS and NMOSD

Principle Investigator: Jay Avasarala, MD / Padmaja Sudhakar, MD

Coordinator: Amanda Wilburn (amanda.wilburn@uky.edu)

Open to enrollment

DATA COLLECTION FROM PATIENTS OF DR. AVASARALA AND DR. SUDHAKAR WITH THESE DISEASES (WE HAVE WAIVER OF INFORMED CONSENT FOR THIS STUDY).

 

MYASTHENIA GRAVIS

 

MG0003

Principle Investigator: Zabeen Mahuwala, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Open to enrollment

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

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

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

 

MG0004

Principle Investigator: Zabeen Mahuwala, MD

Coordinator: Dawn Baker (dawn.baker1@uky.edu)

Open to enrollment

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)

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

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

 

 

STROKE

 

ARCADIA

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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.

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

 

ARCADIA-CSI

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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

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.

 

ASPIRE

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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

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

 

CREST-2

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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

There are two equally important primary hypotheses, which will be tested in two independent parallel, 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

 

Lumosa LT3001-201

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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).

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).

 

MOST

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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.

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

 

SleepSMART

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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

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

 

Statins Use in Intracerebral Hemorrhage Patients

Principle Investigator: L. Creed Pettigrew, MD

Coordinator: Pat Arnold (pat.arnold@uky.edu)

Open to enrollment

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

 

Upcoming studies:

  • Tempo-3 Trial -  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 Levodopa-Treated Adults With Motor Fluctuations (Tempo-3 Trial).  Mid-Stage PD patients with motor fluctuations, H&Y 2.0-3.  Open label extension study available to those who complete the double-blind study. PI:  Zain Guduru, MD, Study Coordinators – Michael Nsoesie at Michael.nsoesie@uky.edu  or Renee Wagner at renee.wagner@uky.edu.
  • Tempo-4 Trial - 58-Week Open-Label Trial Of Tavapadon In Parkinson’s Disease.  Open label extension study for completer patients of Tempo-1 and Tempo-3 studies to provide continued access to study drug.  PI:  Zain Guduru, MD, Study Coordinators – Morgan Yazell at morgan.yazell@uky.edu or Michael Nsoesie at Michael.nsoesie@uky.edu.
  • Shine study - BK-JM-201 – Dyskinesia in PD patients.  A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson’s Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and its Individual Components.  Patients that complete part 1 are also eligible to participate in part 2.
  • AVP 786 - A Phase 2, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in patients with traumatic brain injury (TBI). This is a 12 week study whereby 6-8 patients will be enrolled to evaluate the efficacy and safety of IP AVP-786 compared to placebo for treatment of neurobehavioral disinhibition including aggression, agitation and irritability in patients with TBI. PI: Daniel Lee, MD. Study coordinator – Michael Nsoesie at Michael.nsoesie@uky.edu.
  • GEMINI II - efficacy of SAR442168 compared to placebo (Aubagio) in patients with relapsing MS. PI – Jay Avasarala, MD, Josh Chalkley, MD. Study coordinator – Amanda Wilburn at Amanda.wilburn@uky.edu.
  • PERSEUS - efficacy of SAR442168 compared to placebo (Aubagio) in patients with primary progressive MS. PI – Jay Avasarala, MD, Josh Chalkley, MD.
  • ALXN1210-MG-306 - Phase PI: Dr. Zabeen Mahuwala; Coordinator: Amanda Wilburn/Dawn Baker; Contact: Amanda Wilburn 859-323-7452; Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients with Generalized Myasthenia Gravis
  • CIDP01; PI: Dr. Zabeen Mahuwala; Coordinator: Amanda Wilburn/Dawn Baker; Contact: Amanda Wilburn 859-323-7452; A MULTICENTER, RANDOMIZED, SUBJECT-BLIND, INVESTIGATOR-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF ROZANOLIXIZUMAB IN SUBJECTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP).

  • Alpha synuclein level in REM sleep - using alpha synuclein biomarkers in saliva from patients with REM sleep behavior disorders to predict neurodegeneration. PI – Daniel Lee, MD, Tritia Yamasaki, MD. Study coordinator – Amanda Wilburn at Amanda.wilburn@uky.edu.
  • NOVARTIS – A phase II, patient- and investigator-blinded, randomized, placebo-controlled study to evaluate efficacy, safety and tolerability of BAF312 (siponimod) in patients with stroke due to intracerebral hemorrhage (ICH). PI – Jessica Lee, MD. Study coordinator – Pat Arnold at pat.arnold@uky.edu.

 

No