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:  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 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).

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:  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: 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.

https://clinicaltrials.gov/study/NCT03432286

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.

https://clinicaltrials.gov/study/NCT04616326

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.

https://clinicaltrials.gov/study/NCT04396574

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.

https://clinicaltrials.gov/study/NCT04396236

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

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:  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:  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: 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.

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.

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. 

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. 

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.

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:  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:  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.

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. 

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.  

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

• 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.
• 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.