Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR Tablets in Multiple Sclerosis Patients Who Participated in the MS-F203 Trial
The purpose of this study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months, or until it becomes commercially available whichever comes first, in subjects who previously participated in Acorda Therapeutics Protocol MS-F203.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial|
- Summary of Treatment Emergent Adverse Events (TEAE). [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]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.
- Timed 25 Foot Walk (T25FW) [ Time Frame: Week 2, 14, 26, continuing every 26 weeks until the Final Visit ] [ Designated as safety issue: No ]
- Subject Global Impression (SGI) [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]
Patients asked to complete a Subject Impression questionnaire rating his/her impression of the effects of study drug during the preceding week, specifically in regards to signs and symptoms associated with Multiple Sclerosis (MS).
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 Global Impression of Change (CGIC) [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]
Investigator's overall impression of the patients neurological status and general state of health related to his/her participation in the study; specifically signs and symptoms associated with MS.
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: Screening visit, visit 6 and every 24 months thereafter ] [ Designated as safety issue: No ]
Each patient, based on their baseline neurological exam, are scored according to the EDSS
The EDSS was used to grade patient disability on a scale from 0.0 (normal neurological exam) to 10.0 (death) at the Screening Visit, Visit 6, and Final Visit or Early Termination Visit if applicable.
|Study Start Date:||June 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
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.
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|Study Director:||Bonnie Faust||Acorda Therapeutics|