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| Sponsor: | Acorda Therapeutics |
|---|---|
| Information provided by: | Acorda Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00041717 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spinal Cord Injury Muscle Spasticity |
Drug: Fampridine-SR |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Lakeshore Rehabilitation Hospital | |
| Birmingham, Alabama, United States, 35209 | |
| UAB School of Medicine, 190 Spain Rehab Center | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| United States, Arkansas | |
| Baptist Medical Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Neuro-Therapeutics, Inc | |
| Pasadena, California, United States, 91005 | |
| VA Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304 | |
| Long Beach VA Medical Center | |
| Long Beach, California, United States, 90822 | |
| Santa Clara Valley Medical Center | |
| San Jose, California, United States, 95128 | |
| University of California, Davis | |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| Craig Hospital | |
| Englewood, Colorado, United States, 80110 | |
| United States, Connecticut | |
| Hospital for Special Care | |
| New Britain, Connecticut, United States, 06503 | |
| United States, Delaware | |
| Neurology Associates, P.A. | |
| Wilmington, Delaware, United States, 19806 | |
| United States, District of Columbia | |
| National Rehabilitation Hospital | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Rehabilitation Hospital | |
| Sunrise, Florida, United States, 33351 | |
| United States, Georgia | |
| Shepherd Spinal Center | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Illinois | |
| Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG | |
| Oak Lawn, Illinois, United States, 60453 | |
| Springfield Clinic-Neuroscience Institute | |
| Springfield, Illinois, United States, 62702 | |
| Rehabilitation Institute of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| Hines VA Hospital | |
| Hines, Illinois, United States, 60141 | |
| United States, Massachusetts | |
| HEALTHSOUTH Braintree Rehabilitation Hospital | |
| Braintree, Massachusetts, United States, 02185 | |
| HEALTHSOUTH New England Rehabilitation Hospital | |
| Woburn, Massachusetts, United States, 01801 | |
| Boston University Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Spaulding Rehabilitation Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Mary Free Bed Hospital & Rehabilitation Center | |
| Grand Rapids, Michigan, United States, 49503 | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| Rehabilitation Institute of Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Minneapolis VA Hospital | |
| Minneapolis, Minnesota, United States, 55417 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| University of Missouri | |
| Columbia, Missouri, United States, 65212 | |
| Washington University School of Medicine, Div. of Rehab/Neurology | |
| St. Louis, Missouri, United States, 63110 | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63104 | |
| United States, Montana | |
| Montana Neuroscience | |
| Missouli, Montana, United States | |
| United States, New Jersey | |
| Kessler Institute of Rehabilitation | |
| West Orange, New Jersey, United States, 07052 | |
| United States, New York | |
| SUNY Upstate Clinical Trials Office | |
| Syracuse, New York, United States, 13045 | |
| The Burke Rehabilitation Hospital | |
| White Plains, New York, United States, 10605 | |
| University of Rochester/Strong Memorial Hospital | |
| Rochester, New York, United States, 14642 | |
| Helen Hayes Hospital | |
| West Haverstraw, New York, United States, 13045 | |
| United States, North Carolina | |
| Wake Forest University | |
| Winston Salem, North Carolina, United States, 27157 | |
| UNC Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| East Carolina University | |
| Greenville, North Carolina, United States, 27858 | |
| Coastal AHEC | |
| Wilmington, North Carolina, United States, 28402 | |
| Charlotte Institute of Rehabilitation | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, North Dakota | |
| Clinical Research Services | |
| Bismarck, North Dakota, United States, 58501 | |
| United States, Ohio | |
| Cleveland VAMC | |
| Cleveland, Ohio, United States, 44106 | |
| Drake Center | |
| Cincinnati, Ohio, United States, 45216 | |
| Miami Valley Hospital- Rehabilitation Institute of Medicine | |
| Dayton, Ohio, United States, 45409 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Northeastern Rehabilitation Associates | |
| Scranton, Pennsylvania, United States, 18501 | |
| Bryn Mawr Rehabilitation Hospital | |
| Malvern, Pennsylvania, United States, 19355 | |
| HEALTHSOUTH Harmarville Rehabilitation Hospital | |
| Pittsburgh, Pennsylvania, United States, 15238 | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Good Shepherd Rehabilitation | |
| Allentown, Pennsylvania, United States | |
| United States, Texas | |
| VA North Texas Health Care System | |
| Dallas, Texas, United States, 75216 | |
| Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75390 | |
| United States, Utah | |
| Rehabilitation Services University of Utah Hospitals and Clinics | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Richmond VA Medical Center (Hunter Holmes McGuire) | |
| Richmond, Virginia, United States, 23249 | |
| Hampton VA Hospital | |
| Hampton, Virginia, United States, 23667 | |
| Medical College of Virginia/VCU | |
| Richmond, Virginia, United States, 23298 | |
| INOVA Institute of Research and Education | |
| Falls Church, Virginia, United States, 22042 | |
| United States, Washington | |
| University of Washington Medical Center, Dept. of Rehabilitation | |
| Seattle, Washington, United States, 98195 | |
| United States, West Virginia | |
| CAMC Health Education & Research Institute | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| Wood VA Medical Center | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Canada, Alberta | |
| Glenrose Rehabilitation Hospital | |
| Edmonton, Alberta, Canada, T5G 0B7 | |
| Foothills Provincial General Hospital | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Canada, British Columbia | |
| G.F. Strong Rehabilitation Centre | |
| Vancouver, British Columbia, Canada, V5Z 2G9 | |
| Canada, Manitoba | |
| Health Sciences Centre | |
| Winnipeg, Manitoba, Canada, R3A 1M4 | |
| Canada, New Brunswick | |
| Stan Cassidy Centre for Rehabilitation | |
| Fredericton, New Brunswick, Canada, E3B 4R3 | |
| Canada, Nova Scotia | |
| QEII HSC-Nova Scotia Rehabilitation Centre | |
| Halifax, Nova Scotia, Canada, B3M 4K4 | |
| Canada, Ontario | |
| St. Mary's of the Lake Hospital | |
| Kingston, Ontario, Canada, K7L 5A2 | |
| Parkwood Hospital Site, St. Joseph's Health Care | |
| London, Ontario, Canada, N6C 5J1 | |
| Chedoke-McMaster Hospital | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| The Rehabilitation Centre | |
| Ottawa, Ontario, Canada, K1H 8M2 | |
| Toronto Rehabilitation Institute, Lyndhurst Centre | |
| Toronto, Ontario, Canada, M5G 3V9 | |
More Information
| Study ID Numbers: | SCI-F301/302 |
| Study First Received: | July 12, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00041717 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
spinal cord injury muscle spasticity |
|
Neuromuscular Manifestations Molecular Mechanisms of Pharmacological Action Spinal Cord Diseases Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Cardiovascular Agents Trauma, Nervous System Pharmacologic Actions Membrane Transport Modulators |
Spinal Cord Injuries Signs and Symptoms Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Therapeutic Uses Potassium Channel Blockers Neurologic Manifestations 4-Aminopyridine |
