Sponsor study identifier
interventional
35
1 country
11
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2013
Actual (reported)Study Completion
March 2013
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 7, 2011
Actual (reported)November 9, 2011
Actual (reported)December 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 2013
Actual (reported)March 2013
Actual (reported)June 24, 2014
Actual (reported)Safety and Tolerability of Dalfampridine-ER 10mg in Subjects With Cerebral Palsy (CP)
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
up to 31 days
Measure the Effects of Both Single and Multiple Doses of Dalfampridine-ER 10 mg on Sensorimotor Function
up to 31 days
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
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
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
UCLA/Orthopaedic Hospital Center for Cerebral Palsy
Los Angeles, California, 90095, United States
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Kennedy Krieger Institute at Johns Hopkins University
Baltimore, Maryland, 21205, United States
Detroit Clinical Research Center
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.
Enrique Carrazana, MD
Acorda Therapeutics
35 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Noninvasive Spinal Neuromodulation Enables Locomotor Recovery in Individuals With Cerebral Palsy
Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo
Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Farmington Hills, Michigan, 48334, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, 55101, United States
University of Missouri at Columbia
Columbia, Missouri, 65212, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Primary Completion
January 2013
Actual (reported)Study Completion
March 2013
Actual (reported)Last Updated
June 24, 2014
Results First Posted
June 24, 2014
Record last verified: 2014-05
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Source: ClinicalTrials.gov.
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