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
|ClinicalTrials.gov Identifier: NCT00648908|
Recruitment Status : Completed
First Posted : April 1, 2008
Results First Posted : February 27, 2012
Last Update Posted : February 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: Fampridine-SR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||269 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 Subjects With Multiple Sclerosis Who Participated in the MS-F203 Trial|
|Study Start Date :||June 2006|
|Primary Completion Date :||January 2011|
|Study Completion Date :||April 2011|
- Summary of Treatment Emergent Adverse Events (TEAE). [ Time Frame: up to 5 years ]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 ]
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 ]
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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00648908
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|Study Director:||Bonnie Faust||Acorda Therapeutics|