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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Drug: placebo/dalfampridine-ER; Drug: dalfampridine-ER/placebo

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Acorda Site #011
  • California
    • La Jolla, California, United States, 92103
      • Acorda Site #018
    • Newport Beach, California, United States, 92663
      • Acorda Site #016
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Acorda Site #006
  • Florida
    • Atlantis, Florida, United States, 33462
      • Acorda Site #002
    • Fort Lauderdale, Florida, United States, 33308
      • Acorda Site #015
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Acorda Site #003
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • Acorda Site #021
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Acorda Site #009
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Acorda Site #017
  • Montana
    • Great Falls, Montana, United States, 59405
      • Acorda Site #020
  • Nevada
    • Reno, Nevada, United States, 89502
      • Acorda Site #023
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Acorda Site #022
  • New York
    • Buffalo, New York, United States, 14220
      • Acorda Site #019
    • West Haverstraw, New York, United States, 10993
      • Acorda Site #007
    • White Plains, New York, United States, 10605
      • Acorda Site #004
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Acorda Site #013
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Acorda Site #001
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Acorda Site #008
  • Washington
    • Bellevue, Washington, United States, 98004
      • Acorda Site #010

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Walking Speed Measured by the Timed 25 Foot Walk Test (T25FW)	Screening visit, Days 1, 8, 15, 22, 29 and 36
Motor and Sensory Function as Measured by the Fugl-Meyer Assessment (FMA)	Screening visit, Days 1, 8, 15, 22, 29, and 36
Manual Dexterity as Measured by the Box and Block Test	Days 1, 8, 15, 22, 29, and 36
Assistance Required to Perform Activities of Daily Living (ADL) by the Functional Independence Measure (FIM) Scale	Days 1, 8, 15, 22, 29, and 36
Subject Global Impression (SGI) Scale	Days 8, 15, 22, 29 and 36
Clinician Global Impression (CGI) Scale	Days 8, 15, 22, 29 and 36
Hand Strength as Measured by the Grip Test and Pinch Tests	Days 1, 8, 15, 22, 29, and 36

Collaborators and Investigators

• Sponsor: Acorda Therapeutics
• Investigators: Study Director: Mathews Adera, MD, Acorda Therapeutics

Publications and helpful links

General Publications

• Iaci JF, Parry TJ, Huang Z, Finklestein SP, Ren J, Barrile DK, Davenport MD, Wu R, Blight AR, Caggiano AO. Dalfampridine improves sensorimotor function in rats with chronic deficits after middle cerebral artery occlusion. Stroke. 2013 Jul;44(7):1942-50. doi: 10.1161/STROKEAHA.111.000147. Epub 2013 May 7.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): January 22, 2016
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Potassium Channel Blockers; 4-Aminopyridine
• Other Study ID Numbers: DALF-PS-1003