Neurology Trials
Cervical Dystonia
Sponsor: Ipsen Pharmaceuticals Enrolling
Title: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Dysport® for the Treatment of Cervical Dystonia
Principal Investigator: Allison Brashear, M.D.
Criteria: 18 or older
Cervical dystonia with onset of at least 18 months
Previously treated or previously untreated with botulinum toxin A or B
Contact: Karen Jackson
336-716-9056
kjackson@wfubmc.edu
Sponsor: Ipsen Pharmaceuticals Enrolling
Title: A Phase II, Prospective, Multi-Center, Open Label Extension Study to Assess the Longer Term Safety and Efficacy of Repeated Treatment of Dysport Intramuscular Injection in the Treatment of Cervical Dystonia
Principal Investigator: Allison Brashear, M.D
Criteria: 18 or older
Enrolled in the Double Blind Study and have:
Completed all Double Blind Study visits including Wk 12
or
Completed all study visits up to and including Week 4 in the event of an early withdrawal
Study lasts 12 months with 4 injection visits and injection follow up visits.
Contact: Karen Jackson
336-716-9056
kjackson@wfubmc.edu
ALS Amyotrophic Lateral Sclerosis (Lou Gehrig’s Disease)
Sponsor: The WFUBMC ALS Research Foundation - Enrolling
Title: A prospective survey of cramps and fasciculations in ALS patients
Principal Investigator: James B. Caress, M.D.
Questionnaire Study
Criteria: 30 years or older
ALS onset > 18 months prior to study
Complaint of cramps/fasciculations is not necessary
Contact: Theresa Johnston-Crews, RN
336-716-2323
tjcrews@wfubmc.edu
Sponsor: National Institutes of Health – Enrolling
Title: Amyotrophic Lateral Sclerosis Research Group (ALS RG) Collection of Data and Biomaterial For Repository Banking To Facilitate Research Into The Etiology of ALS and Relate Motor Neuron Diseases.
Principal Investigator: James B. Caress, M.D.
Criteria: Patients with ALS or related motor neuron disease
Control Group – Patients without ALS or related motor neuron disease
Family Medical Questionnaire
Blood Sample Collection
A collection of DNA and cell line from a well-characterized patient population will be available as a resource to qualified researchers investigating the etiology of ALS.
Contact: Theresa Johnston-Crews,RN
336-716-2323
tjcrews@wfubmc.edu
STROKE
Sponsor: National Institutes of Health – Enrolling
Title: Siblings With Ischemic Stroke Study – SWISS
Principal Investigator: David Lefkowitz, M.D.
Criteria: Living siblings that have had an ischemic stroke and agree to have blood drawn for DNA sampling. One time blood draw.
Contact: Emily Smith
336-716-2133
emsmith@wfubmc.edu
Sponsor: National Institutes of Health – Enrolling
Title: Insulin Resistance Intervention After Stroke – IRIS A Multi-center, Double-blind, Placebo Controlled Study That Will Test The Effectiveness of a Medicine Called Pioglitazone Compared With Placebo For Prevention of Recurrent Stroke and Heart Attack in Non Diabetic Patients With a Recent Stroke and Insulin Resistance.
Principal Investigator: David Lefkowitz, M.D.
Criteria: 45 years or older
Not on diabetes medication
Recent stroke (within past 6 months)
Insulin resistant (by blood test)
Four years of follow up with yearly follow up visits
Medications dispensed through mail
Telephone contacts by study nurse
Contact: Emily Smith
336-716-2133
emsmith@wfubmc.edu
Sponsor: National Institutes of Health – Enrolling
Title: Secondary Prevention of Small Subcortical Strokes Two Randomized, Multi-center Clinical Trials Anti-platelet therapy: Aspirin 325 mg vs Aspirin 325 mg plus Clopidogrel 75 mg. Two target levels of systolic blood pressure control Usual (130-149 mmHg vs. Intense (< 130 mmHg)
Principal Investigator: David Lefkowitz, M.D.
Criteria: 40 years or older
Lacunar strokes
No signs/symptoms of cortical dysfunctions
MRI evidence of S3
Patients followed for four years with follow-up clinic visits every 3 months
Hypertension medication available for participants
Sponsor: National Institutes of Health – Enrolling
Title: Enhancing cortical plasticity with nerve stimulation in stroke patients with severe motor deficit
Principal Investigator: Lumy Sawaki, M.D.; Ph.D.
Criteria: Chronic stroke patients with partial recovery of a weak upper extremity after a single ischemic stroke are being recruited Subjects must be able to extend the affected metacarpophalangeal at least 10° and the wrist 20°for this study. Subjects must be able to travel to the Medical Center for training sessions 5 days a week for 2 weeks, and return later for follow-up testing. Additionally, three transcranial magnetic stimulation sessions and three evaluations of motor function will be required.
Contact: Lumy Sawaki
336-713-8459
lsawakir@wfubmc.edu
Sponsor: American Heart Association – Enrolling
Title: Driving neuroplasticity with nerve stimulation and modified CIT
Principal Investigator: Lumy Sawaki, M.D.; Ph.D.
Criteria: Patients at least 21 years of age who have suffered a stroke at least 12 months ago (chronic stroke), which has caused weakness in one hand and/or arm, may be eligible for this study. All costs related to the study and rehabilitation sessions will be covered for those who participate. Involvement will last a total of 13 separate days. During this time, three sessions of transcranial magnetic stimulation of the brain and three evaluations of motor function will be performed. During the remaining 10 days, participants will receive peripheral nerve stimulation followed by occupational therapy sessions.
Contact: Lumy Sawaki
336-713-8459
lsawakir@wfubmc.edu
Sponsor: WFUBMC – Enrolling
Title: Effects of atomoxetine on use-dependent plasticity in chronic stroke patients: a pilot study
Principal Investigator: Lumy Sawaki, M.D.; Ph.D.
Criteria: Chronic stroke patients, male or female, aged 18 to 80 after a single ischemic stroke are being recruited. Subjects must be able to extend and flex the thumb on the paretic side at 0.5 Hz or more. Subject’s involvement will last a total of 2 separate days.
Contact: Lumy Sawaki
336-713-8459
lsawakir@wfubmc.edu
Sponsor: National Institutes of Health – Enrolling
Title: Amphetamine enhanced stroke recovery
WFUBMC Principal Investigator: Lumy Sawaki, M.D.; Ph.D.
Criteria: Patients with motor deficits resulting from hemispheric ischemic stroke within 30 days. This study is being conducted at approximately five hospitals in the United States. Subjects will be in the study for about 3 months. They must be able to participate in one-hour physical therapy for a total of 10 days.
Contact: Lumy Sawaki
336-713-8459
lsawakir@wfubmc.edu
Sponsor: National Institutes of Health – Enrollment completed. Data analyses phase.
Title: Extremity constraint-induced movement therapy to improve arm function in people with stroke
WFUBMC Principal Investigator: Lumy Sawaki, M.D.; Ph.D.
Criteria: Patients presenting within 3 - 9 months of stroke with upper extremity impairment, and who have at least some ability to extend partially the wrist and digits were eligible for this study. The purpose of this study is to determine whether constraint-induced movement therapy is as effective in subacute stroke patients (3 - 9 months poststroke) as it is in chronic stroke patients (> 12 months post-stroke).
Contact: Lumy Sawaki
336-713-8459
lsawakir@wfubmc.edu
Transcranial Doppler and Cerebrovascular Disease
Sponsor: New Health Sciences, Inc. Enrolling
Title: Dynamic Vascular Analysis (DVATM) Indices in an Asymptomatic Reference Population
Principal Investigator: Charles Tegeler IV, M.D.
Criteria: Age: 18 to 80
Healthy male (Preferred)/female: no history of stroke, transient ischemic attack, hypertension, diabetes, high cholesterol, coronary artery disease, or myocardial infarct.
Non-invasive and no discomfort
Contact: Rong Tang, MD
336-716-3929
rtang@wfubmc.edu
MULTIPLE SCLEROSIS
Sponsor: National Institutes of Health (WFHUS is subcontracted by Mt. Sinai School of Medicine Enrolling
Title: A Multicenter, Double blind, Randomized Study comparing the Combined Us Interferon Beta 1-a and Glatiramer Acetate to Either Agent Alone in Patients With Relasping-Remitting Multiple Sclerosis
Principal Investigator: Douglas R. Jeffery, M.D., Ph.D.
Criteria: Age: 18-80
EDSS between 0 and 5.5
2 exacerbations in the last 3 years
Not have had prior use of INF-β and Glatiramer Acetate
Not have evidence of progressive MS
No exacerbations in the 30 days prior to screening
3 year study
Contact: nlawlor@wfubmc.edu
EPILEPSY
Sponsor: UCB Pharma Enrolling
Title: A 19 Week , Randomized, Double-blind, Multicenter, Plabebo-Controlled Safety Study to Evaluate the Cognitive and Neuropsychological Effects of Levetiracetam 20-60 mg/kg/day, Divided in Twice Daily Dosing as Adjunctive Treatment in Children 4-16 Years Old, Inclusive, with Partial Onset Seizures.
Principal Investigator: Maria Sam, M.D.
Criteria: Diagnosis of partial onset seizures for at least 6 months
Currently treated with 1 or 2 Anti-Epileptic Drugs
Have had at least 1 partial onset seizure in the past 4 weeks
Not currently taking Keppra
Does not have a terminal illness or mental retardation
The clinical trial provides in depth neuro-cognitive testing, exams, and medication at no charge.
Patients who complete this trial will be able to participate in a 48 week open label extension.
Contact: Jo Shuping
336-716-8694
jshuping@wfubmc.edu
Sponsor: Ortho-McNeil Enrolling
Title: A Double-Blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate versus Phenytoin in Subjects with Seizures indicative of New Onset Epilepsy.
Principle Investigator: Cormac O’Donovan, M.D.
Criteria: Treatment Naïve, New Onset Epilepsy Patients
Patients receive Topamax or Dilantin
Contact: Jo Shuping
336-716-8694
jshuping@wfubmc.edu
Parkinson ’s Disease
Sponsor: National Institutes of Health Enrolling
Title: Parkinson’s Reserch: The Organized Genetics Initiative (PROGENI).
Principal Investigator: Francis Walker, M.D.
Criteria: Age 20 or older
2 living borthers or sisters with the clinical impression of Parkinson’s Disease Bradykinesia
Progressive Symptoms
Participation involves 1 study visit that will last approximately 2 hours and includes a Neurological exam and blood draw.
Contact: Christine O’Neil
336-716-8611
coneill@wwfubmc.edu
Huntington’s Disease
Sponsor: HP Therapeutics Foundation, Inc Huntington Study Group Enrolling
Title: Cooperative Huntington’s Observational Researach Trial (COHORT)
Principal Investigator: Francis Walker, M.D.
Criteria: Clinical Diagnosis of Huntington’s Disease
First degree relative of Individual with Huntington’s Disease
Spouse of person with Huntington’s Disease.
Contact: Christine O’Neil
336-716-8611
coneill@wwfubmc.edu