Current Clinical Studies

ALS

 

ALXN1210-ALS-308

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

 

 

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.

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

 

 

TAME

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

 

 

HEALEY ALS: Task Order 2

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

 

 

HEALEY ALS: Task Order 3

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

 

 

HEALEY ALS: Task Order 4

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

 

 

HEALEY ALS: Task Order 5

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

 

 

REFALS-ES

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

 

 

BIOBANK

 

NeuroBank

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.

 

 

EPILEPSY

 

Neuropace PAS

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.

 

 

E2007-G000-410

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).

 

 

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.

 

 

EP0093

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

 

 

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

 

 

HEADACHE

 

Erenumab

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

 

 

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

 

 

BouNDless study – ND0612-317

Principal Investigator:  John Slevin, MD

Coordinator:  Michael Nsoesie / Renee Wagner

Status:  Open to enrollment

TITLE:  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 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

 

 

CVL-751-PD-001

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

 

 

DBS Eval

Principal Investigator:  Craig van Horne, MD, PhD.

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

 

 

P2B001/003

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

 

 

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

 

TemPo - 1

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

 

 

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.

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

 

 

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.

 

 

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.

 

 

MULTIPLE SCLEROSIS

 

Click-MS

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

 

 

Diagnosing optic neuritis with or without diagnosis of MS or NMOSD

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.

 

 

Fundus photography and MS

Principal Investigator:  Jay Avasarala, MD

Coordinator:  Amanda Wilburn

Status:  Open to enrollment

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

 

 

GEMINI 2

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

 

 

MS and NMOSD in African American 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.

 

 

PERSEUS

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

 

 

Retinal imaging in MS and NMOSD

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).

 

MYASTHENIA GRAVIS

 

MG0003

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

 

 

MG0004

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

 

 

CIDP01

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

 

 

STROKE

 

ARCADIA

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

 

 

ARCADIA-CSI

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.

 

 

ASPIRE

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

 

 

CREST-2

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 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

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).

 

 

MOST

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

 

 

SleepSMART

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

 

 

Statins Use in Intracerebral Hemorrhage Patients (SATURN)

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

 

 

 

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.
  • 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.

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