Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cerebral Palsy (CP)	Drug: dalfampridine-ER 10mg; Other: Placebo	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, 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
Study Start Date :	December 2011
Actual Primary Completion Date :	January 2013
Actual Study Completion Date :	March 2013

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP) [ Time Frame: up to 31 days ]

   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 :

1. Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function [ Time Frame: up to 31 days ]
   • 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)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bethoux F, Fatemi A, Fowler E, Marciniak C, Mayadev A, Waksman J, Zackowski K, Suarez G, Blight AR, Rabinowicz AL, Carrazana E. Safety, Tolerability, and Sensorimotor Effects of Extended-release Dalfampridine in Adults With Cerebral Palsy: A Pilot Study. Clin Ther. 2017 Feb;39(2):337-346. doi: 10.1016/j.clinthera.2016.12.015. Epub 2017 Jan 25.

Responsible Party:	Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT01468350 History of Changes
Other Study ID Numbers:	DALF-CP-1002
First Posted:	November 9, 2011
Results First Posted:	June 24, 2014
Last Update Posted:	June 24, 2014
Last Verified:	May 2014

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