NCT00649792

Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.

Detailed description

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 has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients over a long period of time.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fampridine-SR	Tablets, 10 mg, BID (twice daily)

Timeline

• Start date: 2007-08-01
• Primary completion: 2011-01-01
• Completion: 2011-04-01
• First posted: 2008-04-01
• Last updated: 2012-02-28
• Results posted: 2012-02-27

Locations

42 sites across 2 countries: United States, Canada