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Home > "S" Clinical Trials Conditions > Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting from Spinal Cord Injury Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting from Spinal Cord Injury
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting from Spinal Cord Injury
For Condition: Spinal Cord Injury,Muscle Spasticity
Status: Completed
Sponsor(s): Acorda Therapeutics ,
Synopsis: Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months) - Moderate to severe lower-limb spasticity - Able to give informed consent and willing to comply with protocol Exclusion Criteria: - Pregnancy - 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
Total Enrollment: 360
Location and Contact Information:
Hampton VA Hospital
Hampton, Virginia, 23667
United States
Hospital for Special Care
New Britain, Connecticut, 06503
United States
Good Shepherd Rehabilitation
Allentown, Pennsylvania,
United States
Cleveland VAMC
Cleveland, Ohio, 44106
United States
VA Palo Alto Health Care System
Palo Alto, California, 94304
United States
Health Sciences Centre
Winnipeg, Manitoba, R3A 1M4
Canada
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Charlotte Institute of Rehabilitation
Charlotte, North Carolina, 28203
United States
Kessler Institute of Rehabilitation
West Orange, New Jersey, 07052
United States
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
United States
Santa Clara Valley Medical Center
San Jose, California, 95128
United States
QEII HSC-Nova Scotia Rehabilitation Centre
Halifax, Nova Scotia, B3M 4K4
Canada
Mayo Clinic
Rochester, Minnesota, 55905
United States
Wake Forest University
Winston Salem, North Carolina, 27157
United States
Hines VA Hospital
Hines, Illinois, 60141
United States
Miami Valley Hospital- Rehabilitation Institute of Medicine
Dayton, Ohio, 45409
United States
Montana Neuroscience
Missouli, Montana,
United States
Craig Hospital
Englewood, Colorado, 80110
United States
G.F. Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
Canada
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
United States
INOVA Institute of Research and Education
Falls Church, Virginia, 22042
United States
HEALTHSOUTH Harmarville Rehabilitation Hospital
Pittsburgh, Pennsylvania, 15238
United States
Parkwood Hospital Site, St. Joseph's Health Care
London, Ontario, N6C 5J1
Canada
Rehabilitation Institute of Michigan
Detroit, Michigan, 48201
United States
Clinical Research Services
Bismark, North Dakota, 58501
United States
Mary Free Bed Hospital & Rehabilitation Center
Grand Rapids, Michigan, 49503
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Minneapolis VA Hospital
Minneapolis, Minnesota, 55417
United States
The Burke Rehabilitation Hospital
White Plains, New York, 10605
United States
Coastal AHEC
Wilmington, North Carolina, 28402
United States
University of Washington Medical Center, Dept. of Rehabilitation
Seattle, Washington, 98195
United States
Neurology Associates, P.A.
Wilmington, Delaware, 19806
United States
Bryn Mawr Rehabilitation Hospital
Malvern, Pennsylvania, 19355
United States
Long Beach VA Medical Center
Long Beach, California, 90822
United States
Chedoke-McMaster Hospital
Hamilton, Ontario, L8N 3Z5
Canada
St. Mary's of the Lake Hospital
Kingston, Ontario, K7L 5A2
Canada
Southwestern Medical Center at Dallas
Dallas, Texas, 75390
United States
Springfield Clinic-Neuroscience Institute
Springfield, Illinois, 62702
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
United States
Lakeshore Rehabilitation Hospital
Birmingham, Alabama, 35209
United States
Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
Oak Lawn, Illinois, 60453
United States
Medical College of Virginia/VCU
Richmond, Virginia, 23298
United States
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
Miami, Florida, 33136
United States
St. Louis University
St. Louis, Missouri, 63104
United States
Richmond VA Medical Center (Hunter Holmes McGuire)
Richmond, Virginia, 23249
United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
United States
HEALTHSOUTH New England Rehabilitation Hospital
Woburn, Massachusetts, 01801
United States
Foothills Provincial General Hospital
Calgary, Alberta, T2N 2T9
Canada
Drake Center
Cincinnati, Ohio, 45216
United States
East Carolina University
Greenville, North Carolina, 27858
United States
Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Ohio State University
Columbus, Ohio, 43210
United States
Northeastern Rehabilitation Associates
Scranton, Pennsylvania, 18501
United States
SUNY Upstate Clinical Trials Office
Syracuse, New York, 13045
United States
Boston University Medical Center
Boston, Massachusetts, 02118
United States
Helen Hayes Hospital
West Haverstraw, New York, 13045
United States
HEALTHSOUTH Braintree Rehabilitation Hospital
Braintree, Massachusetts, 02185
United States
Toronto Rehabilitation Institute, Lyndhurst Centre
Toronto, Ontario, M5G 3V9
Canada
CAMC Health Education & Research Institute
Charleston, West Virginia, 25304
United States
VA North Texas Health Care System
Dallas, Texas, 75216
United States
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 4R3
Canada
Baptist Medical Center
Little Rock, Arkansas, 72205
United States
Glenrose Rehabilitation Hospital
Edmonton, Alberta, T5G 0B7
Canada
Wood VA Medical Center
Milwaukee, Wisconsin, 53295
United States
Washington University School of Medicine, Div. of Rehab/Neurology
St. Louis, Missouri, 63110
United States
University of California, Davis
Sacramento, California, 95817
United States
Shepherd Spinal Center
Atlanta, Georgia, 30309
United States
Rehabilitation Services University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
The Rehabilitation Centre
Ottawa, Ontario, K1H 8M2
Canada
University of Missouri
Columbia, Missouri, 65212
United States
University of Rochester/Strong Memorial Hospital
Rochester, New York, 14642
United States
Rehabilitation Hospital
Sunrise, Florida, 33351
United States
Neuro-Therapeutics, Inc
Pasadena, California, 91005
United States
UAB School of Medicine, 190 Spain Rehab Center
Birmingham, Alabama, 35233
United States
Additional Information:
Study ID Numbers: SCI-F301/302;
Study Start Date: June 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041717
Other Muscle Spasticity Studies:
1. Physical Performance Measures for Manual Wheelchair Users
2. Functional Magnetic Micturition in Patients w/SCI
3. Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries
4. Electrical Control of Bladder in Spinal Cord Injury Patients
5. Study of Bilateral Phrenic Nerve Pacing Via Intramuscular Electrodes Surgically Implanted Into the Diaphragm To Achieve Artificial Ventilation in Patients With Ventilator-Dependent Tetraplegia
Related Studies:
Other Muscle Spasticity Clinical Trials
Other California Clinical Trials
Other Palo Alto Clinical Trials
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting from Spinal Cord Injury
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