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

Acorda Therapeutics83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Ischemic Stroke

Interventions

placebo/dalfampridine-ERDRUG

Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart

dalfampridine-ER/placeboDRUG

Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (20)

Acorda Site #011

Birmingham, Alabama, United States

Acorda Site #018

La Jolla, California, United States

Outcomes

Primary Outcomes

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

Time frame: up to 36 days

Data from ClinicalTrials.gov

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