Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
NCT ID: NCT00041717
Last Updated: 2020-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
213 participants
INTERVENTIONAL
2002-07-31
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
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
Role: STUDY_DIRECTOR
Acorda Therapeutics
Locations
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Lakeshore Rehabilitation Hospital
Birmingham, Alabama, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Baptist Medical Center
Little Rock, Arkansas, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
Neuro-Therapeutics, Inc
Pasadena, California, United States
Neurology Associates, P.A.
Wilmington, Delaware, United States
National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
Miami, Florida, United States
Rehabilitation Hospital
Sunrise, Florida, United States
Shepherd Spinal Center
Atlanta, Georgia, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, United States
Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
Oak Lawn, Illinois, United States
Springfield Clinic-Neuroscience Institute
Springfield, Illinois, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
HEALTHSOUTH Braintree Rehabilitation Hospital
Braintree, Massachusetts, United States
HEALTHSOUTH New England Rehabilitation Hospital
Woburn, Massachusetts, United States
Mary Free Bed Hospital & Rehabilitation Center
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine, Div. of Rehab/Neurology
St Louis, Missouri, United States
Montana Neuroscience
Missoula, Montana, United States
Kessler Institute of Rehabilitation
West Orange, New Jersey, United States
The Burke Rehabilitation Hospital
White Plains, New York, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Clinical Research Services
Bismarck, North Dakota, United States
Drake Center
Cincinnati, Ohio, United States
Cleveland VAMC
Cleveland, Ohio, United States
Good Shepherd Rehabilitation
Allentown, Pennsylvania, United States
Bryn Mawr Rehabilitation Hospital
Malvern, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
HEALTHSOUTH Harmarville Rehabilitation Hospital
Pittsburgh, Pennsylvania, United States
Northeastern Rehabilitation Associates
Scranton, Pennsylvania, United States
Rehabilitation Services University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Hampton VA Hospital
Hampton, Virginia, United States
Richmond VA Medical Center (Hunter Holmes McGuire)
Richmond, Virginia, United States
CAMC Health Education & Research Institute
Charleston, West Virginia, United States
Foothills Provincial General Hospital
Calgary, Alberta, Canada
Glenrose Rehabilitation Hospital
Edmonton, Alberta, Canada
G.F. Strong Rehabilitation Centre
Vancouver, British Columbia, Canada
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, Canada
QEII HSC-Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, Canada
Parkwood Hospital Site, St. Joseph's Health Care
London, Ontario, Canada
The Rehabilitation Centre
Ottawa, Ontario, Canada
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto, Ontario, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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SCI-F301
Identifier Type: -
Identifier Source: org_study_id
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