Primary Outcome Measures:
- Summary of Treatment Emergent Adverse Events (TEAE). [ Time Frame: up to 40 months ]
All adverse events reported were treatment emergent. Therefore, events that had a date of onset, or worsening, on or after the start of the open-label drug and up to 14 days after the last dose (for non-serious events) or up to 30 days after the last dose (for SAEs) were summarized. Any abnormal clinically significant changes in physical examination, medical history, clinical laboratory testing, 12-lead ECG, and standard EEG testing were captured as adverse events.
Secondary Outcome Measures:
- Timed 25-Foot Walk (T25FW) [ Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit ]
- Subject Global Impression (SGI) [ Time Frame: Visit 1 and every clinic visit thereafter (other than the follow-up visit) ]
For the SGI, the potential responses to the effects of the investigational drug during the preceding week were 1=terrible, 2=unhappy, 3=mostly dissatisfied, 4=neutral/ mixed, 5=mostly satisfied, 6=pleased, and 7=delighted.
- Clinician's Global Impression (CGI) [ Time Frame: Visit 1 and every clinic visit thereafter ]
The potential responses were 1=very much improved, 2=much improved, 3=somewhat improved, 4=no change, 5=somewhat worse, 6=much worse, and 7=very much worse.
- Expanded Disability Status Scale (EDSS) [ Time Frame: The Screening Visit, Visit 6, Final Visit or Early Termination Visit (if applicable) ]
The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death)
Tablets, 10 mg, BID (twice daily)
Other Name: 4-aminopyridine
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.