Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis
|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 Patients With Multiple Sclerosis|
- Summary of Treatment Emergent Adverse Events (TEAE). [ Time Frame: over 7 years (2004-2011) ] [ 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: Screening visit, visit 4, every 12 weeks thereafter, Last Regular Visit, Follow Up Visit and Early Termination Visit ] [ Designated as safety issue: No ]
- Subject Global Impression (SGI) [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]The patient was asked to complete a Subject Global Impression (SGI) questionnaire at Visit 1 and every study visit thereafter except the Follow-up visit. This questionnaire asked the patient to rate the effects of the investigational drug on his/her physical well-being during the preceding week, using a 1 to 7 point scale (1 = terrible, 7 = delighted)
- Clinician Global Impression of Change (CGIC) [ Time Frame: visit 1 and every clinic visit ] [ Designated as safety issue: No ]The CGIC was based on the Investigator's overall impression of the patient's neurological status and general state of health related to his or her participation in the study, specifically in regard to signs and symptoms associated with MS. Neurological status was rated according to a 1 to 7 point scale (1 = very much improved, 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 ]
Based on the baseline neurological exam, each patient was scored according to the Expanded Disability Status Scale, which rates disability on a 0 to 10 scale (0 = normal neurologic examination, 10 = death)
*EDSS assessments were not well synchronized to study period because of wide differences in interval between screening and initiation
|Study Start Date:||November 2003|
|Study Completion Date:||April 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Drug: Fampridine-SR b.i.d. (Twice Daily)
Under the original protocol, patients were to have their treatment dose titrated upwards from a starting dose of 10mg b.i.d. to 15mg b.i.d. and then to a stable (maintenance) dose of 20mg b.i.d. The protocol was subsequently revised to lower the maximum maintenance dose. In the most current protocol, all patients were down-titrated to 10mg b.i.d. and maintained at this dose for the greater part of the duration of the study.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654927
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|Study Director:||Bonnie Faust||Acorda Therapeutics|