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Completed

NCT Number: NCT01605825

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Acorda Site #011, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

placebo/dalfampridine-ER

Drug

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/placebo

Drug

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

Primary outcomes

  1. Safety and Tolerability of Dalfampridine-ER in Subjects With Chronic Deficits After Ischemic Stroke Assessed by Number of Treatment Emergent Adverse Events (TEAEs)

    Time frame: 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

Other outcomes

  1. Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)

    Time frame: Screening visit, Days 1, 8, 15, 22, 29 and 36

  2. Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)

    Time frame: Screening visit, Days 1, 8, 15, 22, 29, and 36

  3. Manual Dexterity as Measured by the Box and Block Test

    Time frame: Days 1, 8, 15, 22, 29, and 36

  4. Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale

    Time frame: Days 1, 8, 15, 22, 29, and 36

  5. Subject Global Impression (SGI) Scale

    Time frame: Days 8, 15, 22, 29 and 36

  6. Clinician Global Impression (CGI) Scale

    Time frame: Days 8, 15, 22, 29 and 36

  7. Hand Strength as Measured by the Grip Test and Pinch Tests

    Time frame: Days 1, 8, 15, 22, 29, and 36

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 25, 2012
Registry last updated
Jan 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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