Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials.
This is an open label study to evaluate the safety and tolerability of long term treatment with fampridine-SR 10 mg BID for up to 27 additional months or until availability of commercial product (whichever sooner) following treatment in Acorda sponsored Studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and also the current recommendations of commercially available dalfampridine-ER in the US.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials|
- Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments [ Time Frame: From Screening (Day 0) to Termination (Month 27) ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
10 mg BID for all subjects
Primary Objectives The primary objective of the study is to evaluate the long-term safety and tolerability of fampridine-SR treatment in Canadian subjects with MS who previously participated in the registrational and extension studies conducted by Acorda.
Endpoints The primary endpoints include the safety parameters: adverse events (AEs) and serious adverse events (SAEs), as well as changes in vital signs and clinical laboratory assessments.
Study Location: Canada
Number of planned subjects: Approximately 38 subjects
Study Population: This study will be conducted in Canadian subjects with MS who participated in one of Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT).
Treatments Groups: All subjects will receive fampridine-SR
Duration of Treatment and Follow-up: The duration of the study treatment with fampridine-SR will be up to 27 months or until fampridine-SR becomes commercially available, whichever comes first. The Follow-up period will be 1 month after subjects' last dose of study treatment.
|Foothills Medical Center|
|Calgary, Alberta, Canada|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada|
|Canada, New Brunswick|
|River Valley Health|
|Fredericton, New Brunswick, Canada|
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada|
|Ottawa Hospital General Campus|
|Ottawa, Ontario, Canada|