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Home > "S" Clinical Trials Conditions > Safety and Efficacy study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis  Safety and Efficacy study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
Safety and Efficacy study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
For Condition: Multiple Sclerosis
Status: Completed
Sponsor(s): Acorda Therapeutics ,
Synopsis: Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. 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: - Have a confirmed diagnosis of Multiple Sclerosis - Are able to walk with or without an assisted device EXCLUSION CRITERIA: - Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control - Participating in other investigational drug trials - A medical history or clinical findings that preclude entry into the study - A medication history that precludes entry into the study - Previously treated with 4-aminopyridine (4-AP)
Total Enrollment: 180
Location and Contact Information:
Ohio State University
Columbus, Ohio, 43210
United States
Mt. Sinai School of Medicine - MS Center
New York City, New York, 10029
United States
Fairview MS Center
Minneapolis, Minnesota, 55454
United States
MS Center at Shepherd Center
Atlanta, Georgia, 30309
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Carolinas Medical Center MS Clinic
Charlotte, North Carolina, 28207
United States
USC School of Medicine
Los Angeles, California, 90033
United States
University of Wisconsin
Madison, Wisconsin, 53792
United States
Barrow Neurological Institute at St. Joseph Hospital and Medical Center
Phoenix, Arizona, 85013
United States
University of Texas-Houston
Houston, Texas, 77030
United States
University of Rochester Medical School
Rochester, New York, 14642
United States
Oregon Health Sciences University; MS Center
Portland, Oregon, 97201
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Chicago
Chicago, Illinois, 60637
United States
SUNY Stony Brook
Stony Brook, New York, 11794
United States
University of Calgary and Foothills Hospital
Calgary, Alberta, T2N 2T9
Canada
Gimbel MS Center
Teaneck, New Jersey, 07666
United States
University of Washington MS Clinical Center
Seattle, Washington, 98195
United States
University of New Mexico
Albuquerque, New Mexico, 87131
United States
Swedish Medical MS Center
Seattle, Washington, 98122
United States
Yale University MS Center
New Haven, Connecticut, 06510
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
University of Maryland at Baltimore
Baltimore, Maryland, 21210
United States
St. Michael's Hospital
Toronto, Ontario, M5B 1WB
Canada
Maimonides MS Care Center
Brooklyn, New York, 11219
United States
Additional Information:
Study ID Numbers: MS-F202;
Study Start Date: February 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053417
Other Multiple Sclerosis Studies:
1. Rolipram to Treat Multiple Sclerosis
2. Improving Memory in Patients with Multiple Sclerosis
3. Natural Antioxidants in the Treatment of Multiple Sclerosis
4. Induction Therapy with a Single High Dose Bolus of Intravenous Methotrexate with Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting with a First Acute Demyelinating Event.
5. Registry to Evaluate Novantrone (R) Effects in Worsening Multiple Sclerosis (RENEW)
Related Studies:
Other Multiple Sclerosis Clinical Trials
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Safety and Efficacy study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
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