Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP)Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)Drug: Placebo
- Registration Number
- NCT00053417
- Lead Sponsor
- Acorda Therapeutics
- Brief Summary
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 (Sustained Release, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) 10 milligram (mg) fampridine b.i.d. 3 15 mg fampridine-SR (4-aminopyridine, 4-AP) 15 mg fampridine b.i.d. 4 20 mg fampridine-SR (4-aminopyridine, 4-AP) 20 mg fampridine b.i.d. 1 Placebo Placebo control, twice a day (b.i.d.)
- Primary Outcome Measures
Name Time Method Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test Baseline (placebo run-in period); 12-week stable dose period The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
USC MS Comprehensive Care Center
🇺🇸Los Angeles, California, United States
Shepherd Center
🇺🇸Atlanta, Georgia, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Texas-Houston
🇺🇸Houston, Texas, United States
Swedish Medical MS Center
🇺🇸Seattle, Washington, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
SUNY Stony Brook
🇺🇸Stony Brook, New York, United States
Gimbel MS Center
🇺🇸Teaneck, New Jersey, United States
Fairview MS Center
🇺🇸Minneapolis, Minnesota, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Barrow Neurological Institute at St. Joseph Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Yale University MS Center
🇺🇸New Haven, Connecticut, United States
Mt. Sinai School of Medicine - MS Center
🇺🇸New York, New York, United States
University of Maryland at Baltimore
🇺🇸Baltimore, Maryland, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Carolinas Medical Center MS Center
🇺🇸Charlotte, North Carolina, United States
University of Rochester Medical School
🇺🇸Rochester, New York, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Maimonides MS Care Center
🇺🇸Brooklyn, New York, United States
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Oregon Health Sciences University; MS Center
🇺🇸Portland, Oregon, United States
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States