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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: placebo/dalfampridine-ER
* Drug: dalfampridine-ER/placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo/dalfampridine-ER<br>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 | Drug: placebo/dalfampridine-ER<br>* Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart<br>|
| Placebo Comparator: dalfampridine-ER/placebo<br>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 | Drug: dalfampridine-ER/placebo<br>* Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs) | 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 | up to 36 days |