Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
NCT ID: NCT01683838
Last Updated: 2017-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
204 participants
INTERVENTIONAL
2002-06-30
2004-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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fampridine-SR 50mg/day
Fampridine-SR
25mg bid (twice daily)
Placebo
Placebo
Placebo
Interventions
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Fampridine-SR
25mg bid (twice daily)
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe lower-limb spasticity
* Able to give informed consent and willing to comply with protocol
Exclusion Criteria
* History of seizures
* Existing or history of frequent Urinary Tract Infections
* History of drug or alcohol abuse
* Allergy to pyridine-containing substances
* Received a botox injection 4 months prior to study
* Received an investigational drug within 30 days
* Previously treated with 4-aminopyridine (4-AP)
* Not on stable medication dosing in 3 weeks prior to study
* Abnormal ECG or laboratory value at screening
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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Andrew Blight, MD
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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UAB School of Medicine, 190 Spain Rehab Center
Birmingham, Alabama, United States
Long Beach VA Medical Center
Long Beach, California, United States
University of California, Davis
Sacramento, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
Craig Hospital
Englewood, Colorado, United States
Hospital for Special Care
New Britain, Connecticut, United States
Hines VA Hospital
Hines, Illinois, United States
Boston University Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Rehabilitation Institute of Michigan
Detroit, Michigan, United States
Minneapolis VA Hospital
Minneapolis, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
St. Louis University
St Louis, Missouri, United States
University of Rochester/Strong Memorial Hospital
Rochester, New York, United States
SUNY Upstate Clinical Trials Office
Syracuse, New York, United States
Helen Hayes Hospital
West Haverstraw, New York, United States
Charlotte Institute of Rehabilitation
Charlotte, North Carolina, United States
Coastal AHEC
Wilmington, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Miami Valley Hospital- Rehabilitation Institute of Medicine
Dayton, Ohio, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
VA North Texas Health Care System
Dallas, Texas, United States
Southwestern Medical Center at Dallas
Dallas, Texas, United States
INOVA Institute of Research and Education
Falls Church, Virginia, United States
Medical College of Virginia/VCU
Richmond, Virginia, United States
University of Washington Medical Center, Dept. of Rehabilitation
Seattle, Washington, United States
Wood VA Medical Center
Milwaukee, Wisconsin, United States
Health Sciences Centre
Winnipeg, Manitoba, Canada
Chedoke-McMaster Hospital
Hamilton, Ontario, Canada
St. Mary's of the Lake Hospital
Kingston, Ontario, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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SCI-F302
Identifier Type: -
Identifier Source: org_study_id
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