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Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01468350
First received: November 7, 2011
Last updated: May 22, 2014
Last verified: May 2014
History of Changes
  Purpose
A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function

Condition Intervention Phase
Cerebral Palsy (CP)
 Drug: dalfampridine-ER 10mg
Other: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Crossover Study in Subjects With Cerebral Palsy to Evaluate the Safety and Tolerability and the Effect on Sensorimotor Function of Dalfampridine-ER

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) [ Time Frame: up to 31 days ] [ Designated as safety issue: Yes ]

    Safety and tolerability will be assessed primarily by monitoring Treatment Emergent Adverse Events (TEAEs)

    TEAEs are defined as Adverse Events (AEs) with date of onset (or worsening) on or after the start-date of double-blind treatment and no more than 5 days after the last dose of double-blind treatment for Part A of the study and no more than 9 days for Part B of the study.

    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


Secondary Outcome Measures:
  • Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function [ Time Frame: up to 31 days ] [ Designated as safety issue: No ]
    • Hand strength as measured by a composite Z-score derived from the grip test, and key, tip and palmar pinch tests
    • Manual dexterity as measured by the Box and Block Test
    • Walking speed as measured by the Timed 25 Foot Walk (T25FW)
    • Gait as measured by gait analysis equipment (to be performed by sites that have the capability to perform it)

    • For Part B only, subjective impressions of treatment as measured by:

      • Subject Global Impression (SGI)
      • Clinician Global Impression (CGI)
Enrollment: 35
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: (PART A) AB: dalfampridine-ER 10mg then placebo
Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart
 Drug: dalfampridine-ER 10mg Other: Placebo
Placebo Comparator: (PART A) BA: placebo then dalfampridine-ER 10mg
Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart
 Drug: dalfampridine-ER 10mg Other: Placebo
Placebo Comparator: (PART B) AB: dalfampridine-ER 10mg then placebo
Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
 Drug: dalfampridine-ER 10mg Other: Placebo
Placebo Comparator: (PART B) BA: Placebo then dalfampridine-ER 10mg
Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
 Drug: dalfampridine-ER 10mg Other: Placebo

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of CP
  • No previous use of any dalfampridine formulation
  • Ability to perform all the required study procedures. Subjects should be capable of fully extending and flexing both hands

Exclusion Criteria:

  • Presence of any progressive neurological disease
  • Severe CP defined as the requirement to use a wheelchair at all times and a care taker for constant assistance in daily activities. This definition includes spastic quadriplegia
  • Pregnant or breastfeeding
  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: NCT01468350

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
UCLA/Orthopaedic Hospital Center for Cerebral Palsy
Los Angeles, California, United States, 90095
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
United States, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
Kennedy Krieger Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Michigan
Detroit Clinical Research Center
Farmington Hills, Michigan, United States, 48334
United States, Minnesota
Gillette Children's Specialty Healthcare
St. Paul, Minnesota, United States, 55101
United States, Missouri
University of Missouri at Columbia
Columbia, Missouri, United States, 65212
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Enrique Carrazana, MD Acorda Therapeutics
  More Information

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01468350     History of Changes
Other Study ID Numbers: DALF-CP-1002 
Study First Received: November 7, 2011
Results First Received: March 24, 2014
Last Updated: May 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
 Brain Diseases
Central Nervous System Diseases
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016