A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke



Status:Completed
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 85
Updated:4/21/2016
Start Date:May 2012
End Date:March 2013

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This is a multi-center, safety and tolerability study in subjects with chronic stable
sensorimotor deficits after ischemic stroke. It has been designed as a double-blind,
placebo-controlled, 2-period crossover study.


Inclusion Criteria:

- History of a stable sensorimotor deficit due to an ischemic stroke, as confirmed by
the Investigator with supportive prior imaging findings (MRI/ CT scan)

- ≥ 6 months post-stroke

- Have a body mass index (BMI) ranging between 18.0 - 35.0 kg/m,2 inclusive

- Stable concomitant medication therapy regimen within 4 weeks of screening visit

Exclusion Criteria:

- History of seizures, except simple febrile seizures

- Moderate or severe renal impairment as defined by a calculated creatinine clearance
of ≤ 50 mL/minute using the Cockcroft-Gault Equation

- Botulinum toxin use within 2 months prior to the Screening Visit

- Orthopedic surgical procedures in any of the extremities within the past 6 months

- Diagnosis of multiple sclerosis
We found this trial at
20
sites
Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Atlantis, Florida 33462
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Atlantis, FL
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Bellevue, Washington 98004
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Bellevue, WA
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Birmingham, Alabama 35294
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Birmingham, AL
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Boston, Massachusetts 02118
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Boston, MA
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Buffalo, New York 14220
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Buffalo, NY
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Charlotte, North Carolina 28204
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Charlotte, NC
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Decatur, Georgia 30033
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Decatur, GA
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Fairfield, Connecticut 06824
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Fairfield, CT
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Fort Lauderdale, Florida 33308
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Fort Lauderdale, FL
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Great Falls, Montana 59405
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Great Falls, MT
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La Jolla, California 92103
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La Jolla, CA
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Lexington, Kentucky 40513
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Lexington, KY
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New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Newport Beach, California 92663
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Newport Beach, CA
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Norfolk, Virginia 23507
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Norfolk, VA
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Reno, Nevada 89502
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Reno, NV
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Saginaw, Michigan 48604
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Saginaw, MI
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West Haverstraw, New York 10993
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West Haverstraw, NY
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White Plains, New York 10605
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White Plains, NY
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