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Sponsored by: |
Acorda Therapeutics |
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Information provided by: | Acorda Therapeutics |
ClinicalTrials.gov Identifier: | NCT00041717 |
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 |
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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 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SCI-F301/302 |
Study First Received: | July 12, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00041717 |
Health Authority: | United States: Food and Drug Administration |
spinal cord injury muscle spasticity |
Spinal Cord Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Spinal Cord Injuries Signs and Symptoms |
Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neurologic Manifestations 4-Aminopyridine |
Membrane Transport Modulators Neuromuscular Manifestations Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Nervous System Diseases Potassium Channel Blockers Cardiovascular Agents Pharmacologic Actions |