Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT00053417

Run by

Acorda Therapeutics

People needed

206

Starts

2003-02-01

Expected to finish

2003-12-01

Last updated by the study team

2011-08-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a confirmed diagnosis of Multiple Sclerosis
• Are able to walk with or without an assisted device

You may not qualify if…

• 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)

Where it is running

• Barrow Neurological Institute at St. Joseph Hospital and Medical Center — Phoenix, Arizona, United States
• USC MS Comprehensive Care Center — Los Angeles, California, United States
• Yale University MS Center — New Haven, Connecticut, United States
• Shepherd Center — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• University of Maryland at Baltimore — Baltimore, Maryland, United States
• Fairview MS Center — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Gimbel MS Center — Teaneck, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Maimonides MS Care Center — Brooklyn, New York, United States
• Mt. Sinai School of Medicine - MS Center — New York, New York, United States
• University of Rochester Medical School — Rochester, New York, United States
• SUNY Stony Brook — Stony Brook, New York, United States
• Carolinas Medical Center MS Center — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Oregon Health Sciences University; MS Center — Portland, Oregon, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, 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
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• Foothills Medical Centre — Calgary, Alberta, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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