Research : Clinical Research

Clinical Research

The physicians and scientists in the Department of Neurology continually search for better treatment and prevention of complex neurological disorders by conducting interdisciplinary, cutting-edge research. From the bench to the bedside, research is at the forefront of our mission and our faculty collaborate with the Departments of Neurosurgery, Human Genetics, Radiology, and others to address important questions in Alzheimer’s disease, epilepsy, movement disorders like Parkinson’s and multiple sclerosis, stroke, ALS and other neuromuscular diseases, and neuro rehabilitation.

We conduct basic and clinical research in each of our specialty divisions:

Epilepsy
Study Description Enrollment Status
Vertex-765 A Phase 2, Randomized, Double-blind, Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy Not Enrolling
Memantine Study Efficacy and Safety of the Use of Memantine for Preserving Cognition in Adult Patients with Epilepsy. Actively Enrollment
ASERT Assessment of Suicidality in Epilepsy-Rating Tools (ASERT) Actively Enrolling
Lamotrigine-IR vs. Lamotrigine-XR Determination of Relative and Absolute Bioavailability and Clearance of Lamotrigine-IR and Lamotrigine-XR by a Stable-Isotope Technique in Older Patients Closed
SP 615 A Open-Label, Extension Trial to Determine Tolerability and Efficacy of Long-Term Oral SPM 927 as Adjunctive Therapy in Patients with Partial Seizures (Incorporating Amendment 1 & 2) Protocol SP 615. Not Enrolling
Retigabine A multicenter, open-label, long term, safety, tolerability and efficacy study of retigabine in adult epilepsy patients with partial-onset seizures ( Extension of Study VRXRET – E22 – 301 ) VRX-RET-E22-303 Not Enrolling
Movement Disorder Studies
Study Description Enrollment Status
STEADY-PD Isradipine vs placebo in the treatment of patients with early, treated Parkinson’s Disease Enrolling
QE3 Coenzyme Q10 vs placebo in the treatment of patients with early, untreated Parkinson’s Disease Enrolling
NET-PD LS-1 Creatine vs placebo in the treatment of patients with early, treated Parkinson’s Disease Enrolling
Rotigotine (Neupro®) vs placebo (SP921) Rotigotine (Neupro®) vs placebo in patients with advanced-stage Parkinson’s disease Enrolling
URGE-PD Vesicare vs placebo in the treatment of urinary frequency in patients with Parkinson’s Disease Enrollment Pending
Pramipexole IR vs Ropinirole (BIPI) Pramipexole IR vs Ropinirole in patients with early Parkinson’s Disease Not Enrolling
ANS Deep Brain Stimulator (DBS) surgical study Not Enrolling
TEVA 501 Open label study on the long-term effects of rasagiline in patients with Parkinson’s Disease participated in the ADAGIO study Not Enrolling
COHORT Cooperative Huntington Observational Research Trial to study the genetics and environmental factors of Huntington’s Disease Enrolling
2CARE [Coenzyme Q10 (CoQ)] Coenzyme Q10 vs placebo in the treatment of early-stage Huntington’s Disease Enrolling
HORIZON Dimebon vs placebo in the treatment of mild to moderate dementia in patients with Huntington’s Disease Enrolling
CD-PROBE Informational study for patients with Cervical Dystonia new to the study physician’s practice or new to botulinum toxin Enrolling
Multiple Sclerosis
Study Description Enrollment Status
GALA Study A multinational and multicenter study performed in patients with Relapsing – Remitting Multiple Sclerosis (RRMS) to access the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection. Actively Enrolling
SURPASS A multicenter study to evaluate the benefits of switching therapies (Glatiramer Acetate (GA) or interferon b1a) to Natalizumab in patients with Relapsing – Remitting Multiple Sclerosis. Enrollment closed
BAF A phase II multicenter study evaluating safety and efficacy of BAF 312 given orally in patients with Relapsing – Remitting Multiple Sclerosis. Enrollment closed
STRATIFY 2 JCV Antibody Program in patients with Relapsing – Remitting Multiple Sclerosis receiving or considering treatment with Tysabri-Stratify 2. Pending Enrollment
109MS302 A multicenter study to evaluate the efficacy and safety of BG00012 in subjects with relapsing-remitting multiple sclerosis (CONFIRM). Actively Enrolling
FTY720 A multicenter study comparing the efficacy and safety of fingolimod versus placebo in patients with relapsing-remitting multiple sclerosis. Enrollment Closed
CombiRx-Phase III A multicenter study comparing the efficacy and safety of fingolimod versus placebo in patients with relapsing-remitting multiple sclerosis Enrollment Closed
MAESTRO MBP8298 vs placebo in patients with secondary progressive Multiple Sclerosis Enrolling
CombiRX Interferon beta-1a and glatiramer acetate vs either agent alone in patients with relapsing-remitting Multiple Sclerosis Enrolling
Fingolimod administered orally vs placebo Fingolimod administered orally vs placebo in patients with relapsing-remitting Multiple Sclerosis Enrolling
Teriflunomide vs placebo Teriflunomide vs placebo in patients with a clinical episode suggestive of Multiple Sclerosis Enrolling
CONFIRM BG00012 in patients with relapsing-remitting Multiple Sclerosis Enrolling
SPRINT-MS A Randomized, DoubleBlind, PlaceboControlled Study to Evaluate the Safety, Tolerability and Activity of Ibudilast (MN166) in Subjects with Progressive Multiple Sclerosis Enrolling
Neuropsychology
Study Description Enrollment Status
NPH Study of factors contributing to outcome in patients with NPH receiving programmable shunts Enrolling
UPDRS vs normal Study of UPDRS-defined Parkinson’s Disease to identify demographic, motor, and cognitive factors linked to mental status decline Enrolling
DBS Assessment of cognitive, affective, and quality of life performance of DBS patients Enrolling
Stroke
Study Description Enrollment Status
MyRIAD Investigates the possible causes of stroke or TIA in individuals that have a narrowed brain artery (Intracranial Atherosclerotic Disease). Funded by NINDS.
Principal Investigator: Jose Romano, MD
Actively Enrolling
PRISMS Evaluates the efficacy and safety of the drug alteplase (IV-tPA) in patients that suffered a mild, non-disabling stroke. Funded by Genentech.
Principal Investigator: Amer Malik, MD
Enrolling
iDEF Examines the effects of the study drug deferoxamine on Intracerebral Hemorrhage (ICH) with the purpose to learn more about the safety of this investigational drug to remove iron from the brain after a brain hemorrhage. Funded by NINDS.
Principal Investigator: Kristine O’Phelan, MD
Enrolling
RESPECT-ESUS Compares the effectiveness and safety of the oral anticoagulant dabigatran exilate compared to aspirin in patients with Embolic Stroke of Undetermined Source. Funded by Boehringer Ingelheim.
Principal Investigator: Sebastian Koch, MD
Enrolling
MaRISS Evaluates what are the long-term consequences of those with mild or rapidly improving stroke symptoms. Funded by Genentech, Inc.
Principal Investigator: Jose Romano, MD
Pending Enrollment
CREST-2 Compares carotid revascularization plus intensive medical management vs. intensive medical management alone in patients with asymptomatic high-grade carotid stenosis. Patients will be randomized in a 1:1 ratio to endarterectomy vs. no endarterectomy and the other study group will randomize patients in a 1:1 ratio to carotid stenting with embolic protection vs. no stenting. All study patients will receive medical management. Funded by NINDS.
Principal Investigator: Seemant Chaturvedi, MD
Enrolling
TREVO Registry The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the brain vessels by removing clots in patients experiencing a stroke. Funded by Stryker Neurovascular.
Principal Investigator: Dileep Yavagal, MD
Enrolling
STRATIS Registry Evaluates the outcomes associated with the use of devices intended to restore blood flow in patients experiencing acute ischemic stroke. Funded by Medtronic- MITG.
Principal Investigator: Dileep Yavagal, MD
Research registry collecting prospective data
Separator 3D Penumbra Evaluates the safety and effectiveness of the Penumbra System with the Separator 3D for the revascularization of large vessel occlusion vs the Penumbra System alone. Funded by Penumbra, Inc.
Principal Investigator: Dileep Yavagal, MD
Enrolling
Stroke Prevention/ Intervention Research Program (SPIRP) Through the Florida-Puerto Rico Stroke Registry (created and maintained by the project), the study examines both the acute and follow-up care provided to stroke patients in FL and PR in an effort to identify, address, and reduce stroke disparities in both regions. Funded by NIH/NINDS.
Principal Investigator: Ralph Sacco, MD
Research registry collecting prospective data
The Safety and Tolerability of an Aerobic and Resistance Exercise Program with or without Cognitive Training Post-stroke A brain and body training study for people who had a recent stroke. This study provides a series of tasks or activities that may improve cognitive and physical abilities. The investigators want to identify how improvements in fitness lead to brain changes that improve cognitive function. Funded by the American Heart Association and ASA-Bugher Foundation.
Principal Investigator: Clinton Wright, MD
Enrolling
ERICH A study to evaluate the ethnic and racial variations of Intracerebral Hemorrhage in Black, White and Hispanic patients. Funded by NIH/NINDS.
Principal Investigator: Sebastian Koch, MD
Enrolling
NeuSTART 2 A Phase 2, randomized study to evaluate the safety and efficacy of high dose lovastatin versus placebo (or standard dose lovastatin) for three days in patients with acute ischemic stroke. Funded by NIH/ NINDS.
Principal Investigator: Jose Romano, MD
Enrollment closed
MultiStem Treatment of ischemic stroke-induced damage via infusion of MultiStem. MultiStem is a cell therapy medicinal product originating from adherent stem cells taken from the bone marrow of a non-related donor and expanded ex vivo. Funded by Athersys.
Principal Investigator: Dileep Yavagal, MD
Enrollment closed
Stroke Incidence and Risk Factors in a Tri-Ethnic Region Entering its 23rd year, the study follows a racially/ethnically diverse cohort from Northern Manhattan to study stroke risk factors, MI, and vascular death. As the cohort ages, predictors (including biomarkers) of cognitive impairment and the importance of subclinical MRI are being evaluated. Funded by NIH/NINDS.
Principal Investigator: Ralph Sacco, MD
Enrollment closed
Family Study of Stroke Risk and Carotid Atherosclerosis The goal of this study is to identify genetic factors that may represent risk for stroke in a population with certain cerebrovascular phenotypes (observable characteristics). Funded by NIH/NINDS.
Principal Investigator: Ralph Sacco, MD
Enrollment closed
VA
Study Description Enrollment Status
Hypoxemia in Sleep Apnea Therapy in patients with a stroke and/or transient ischemic attack due to a presumed paradoxical embolism through a patent foramen ovale Not enrolling
Multi-center Longitudinal Study Albumin in acute stroke trial Actively Enrolling
Sleep-wake disturbances Secondary prevention of small, subcorical strokes Actively Enrolling
Snoring and Insomnia Therapy in patients with a history of atherosclerotic disease: thrombin receptor antagonist in secondary prevention Not enrolling
Serotonergic antidepressants and REM without atonia Randomized multicenter clinical trial of unruptured brain arteriovenous malformations Not Enrolling
White Matter disease Warfarin vs. Aspirin in reduced cardiac ejection fraction Not enrolling
Cocaine related hemorrhagic strokes Warfarin vs. Aspirin in reduced cardiac ejection fraction Not enrolling
Neuromuscular
Study Description Enrollment Status
Arimoclomol Study to test Arimoclomol as compared with placebo in patients with SOD1+ familial ALS Actively Enrolling
PRESS-ALS The PRE- Symptomatic Studies in ALS (PRESS-ALS) Actively enrolling
Eculizumab A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of eculizumab in subjects with refractory generalized myasthenia gravis Enrolling
Clinical Research in ALS (CRiALS) Study to identify families with ALS Actively Enrolling
Pre-Familial ALS Study (Pre-fALS) Longitudinal observational study of people who are at risk of developing familial ALS (fALS) Actively Enrolling
Noninvasive assessment of neuromuscular disease using electrical impedance Evaluation of a new handheld device for assessing muscle health Actively Enrolling
Novartis CFTY720I220 A double-blind, randomized, multicenter, placebo controlled, parallel-group study to evaluate the efficacy and safety of fingolimod 0.5 mg administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Actively Enrolling
GSK BEL115123 A randomized, placebo controlled, double blind study to evaluate the efficacy, safety, tolerability and pharmacodynamics of belimumab in subjects with Generalized Myasthenia Gravis Actively Enrolling
IgPro20 3003 CSP (PATH) Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study Still pending SIV to start enrolling patients
LEMS – 002 A Phase 3, Multicenter, Double-blind, Placebo-controlled Randomized Discontinuation Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Patients with Lambert-Eaton Myasthenic Syndrome (LEMS) Still pending SIV to start enrolling patients
Rituximab in MG A Phase II Trial of Rituximab in Myasthenia Gravis Enrolling