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
|ClinicalTrials.gov Identifier: NCT00649792|
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : February 27, 2012
Last Update Posted : February 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Fampridine-SR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||214 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2007|
|Primary Completion Date :||January 2011|
|Study Completion Date :||April 2011|
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00649792
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|Study Director:||Bonnie Faust||Acorda Therapeutics|