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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01605825
First received: May 21, 2012
Last updated: December 18, 2015
Last verified: December 2015
  Purpose
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.

Condition Intervention Phase
Ischemic Stroke
Drug: placebo/dalfampridine-ER
Drug: dalfampridine-ER/placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Phase 2b Study of Dalfampridine 10mg Extended Release Tablet in Subjects With Chronic Deficits After Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW) [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA) [ Time Frame: Screening visit, Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • Manual Dexterity as Measured by the Box and Block Test [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subject Global Impression (SGI) Scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Clinician Global Impression (CGI) Scale [ Time Frame: Days 8, 15, 22, 29 and 36 ] [ Designated as safety issue: No ]
  • Hand Strength as Measured by the Grip Test and Pinch Tests [ Time Frame: Days 1, 8, 15, 22, 29, and 36 ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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

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

Drug: dalfampridine-ER/placebo
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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605825

  Show 20 Study Locations
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Mathews Adera, MD Acorda Therapeutics
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01605825     History of Changes
Other Study ID Numbers: DALF-PS-1003 
Study First Received: May 21, 2012
Results First Received: January 28, 2014
Last Updated: December 18, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
4-Aminopyridine
Stroke
Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016