Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy
NCT ID: NCT01468350
Last Updated: 2014-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2011-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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(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
dalfampridine-ER 10mg
Placebo
(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
dalfampridine-ER 10mg
Placebo
(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
dalfampridine-ER 10mg
Placebo
(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
dalfampridine-ER 10mg
Placebo
Interventions
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dalfampridine-ER 10mg
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Acorda Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Enrique Carrazana, MD
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
UCLA/Orthopaedic Hospital Center for Cerebral Palsy
Los Angeles, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Kennedy Krieger Institute at Johns Hopkins University
Baltimore, Maryland, United States
Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
University of Missouri at Columbia
Columbia, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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DALF-CP-1002
Identifier Type: -
Identifier Source: org_study_id
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