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
White Plains, New York 10605
1301
mi
from
White Plains, NY
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Atlantis, Florida 33462
1287
mi
from
Atlantis, FL
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Bellevue, Washington 98004
1405
mi
from
Bellevue, WA
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Birmingham, Alabama 35294
683
mi
from
Birmingham, AL
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Boston, Massachusetts 02118
1443
mi
from
Boston, MA
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Buffalo, New York 14220
1056
mi
from
Buffalo, NY
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Charlotte, North Carolina 28204
957
mi
from
Charlotte, NC
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Decatur, Georgia 30033
805
mi
from
Decatur, GA
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Fairfield, Connecticut 06824
1325
mi
from
Fairfield, CT
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Fort Lauderdale, Florida 33308
1306
mi
from
Fort Lauderdale, FL
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Great Falls, Montana 59405
957
mi
from
Great Falls, MT
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La Jolla, California 92103
1142
mi
from
La Jolla, CA
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Lexington, Kentucky 40513
719
mi
from
Lexington, KY
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New Brunswick, New Jersey 08901
1263
mi
from
New Brunswick, NJ
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Newport Beach, California 92663
1161
mi
from
Newport Beach, CA
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Norfolk, Virginia 23507
1182
mi
from
Norfolk, VA
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Philadelphia, Pennsylvania 19107
1225
mi
from
Philadelphia, PA
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Reno, Nevada 89502
1185
mi
from
Reno, NV
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Saginaw, Michigan 48604
826
mi
from
Saginaw, MI
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West Haverstraw, New York 10993
1289
mi
from
West Haverstraw, NY
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