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

Phase 2

Completed

Interventions: Drug: placebo/dalfampridine-ER
Drug: dalfampridine-ER/placebo

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
placebo/dalfampridine-ER	placebo/dalfampridine-ER	Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36
dalfampridine-ER/placebo	dalfampridine-ER/placebo	Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study: Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)	up to 36 days	A TEAE is defined as any adverse event with date of onset (or worsening) on or after the start-date of double-blind treatment through 7 days after the last dose of double-blind treatment. The severity categories of mild, moderate or severe, are defined below: * Mild is defined as causing no limitation of usual activities * Moderate is defined as causing some limitation of usual activities * Severe is defined as causing inability to carry out usual activities

Secondary Outcome Measures

Name	Time	Method

Locations (20): Acorda Site #006
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Fairfield, Connecticut, United States
Acorda Site #020
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Great Falls, Montana, United States
Acorda Site #023
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Reno, Nevada, United States
Acorda Site #022
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New Brunswick, New Jersey, United States
Acorda Site #018
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La Jolla, California, United States
Acorda Site #003
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Decatur, Georgia, United States
Acorda Site #016
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Newport Beach, California, United States
Acorda Site #015
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Fort Lauderdale, Florida, United States
Acorda Site #002
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Atlantis, Florida, United States
Acorda Site #013
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Charlotte, North Carolina, United States
Acorda Site #009
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Boston, Massachusetts, United States
Acorda Site #021
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Lexington, Kentucky, United States
Acorda Site #017
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Saginaw, Michigan, United States
Acorda Site #004
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White Plains, New York, United States
Acorda Site #019
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Buffalo, New York, United States
Acorda Site #007
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West Haverstraw, New York, United States
Acorda Site #010
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Bellevue, Washington, United States
Acorda Site #001
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Philadelphia, Pennsylvania, United States
Acorda Site #008
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Norfolk, Virginia, United States
Acorda Site #011
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Birmingham, Alabama, United States