Open-Label Study to Assess the Effect of Fampridine-PR on Quality of Life as Reported by Subjects With Multiple Sclerosis (ENABLE)
A multicenter, open-label study to assess subject QoL as reported by responders to long-term treatment fampridine-PR 10 mg twice daily. Subjects classified as non-responders (those who did not meet criteria for continued fampridine treatment in this study) at Week 4 will stop treatment but will continue to provide QoL data for comparative purposes.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis|
- Physical componenet scale of the SF36 health questionnaire in treatment responders [ Time Frame: Change is measured over months 3,6,9 and 12 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
All patients take 10 Mg fampridine twice daily for the first 4 weeks. If deemed treatment responder to continue 10 mg fampridine twice daily for 44 weeks. Non treatment responders can continue without treatment by completing quality of life questionnaires.
10 Mg twice daily
This is a multicenter, open-label study to assess QoL as reported by responders to long-term treatment with prolonged-release fampridine 10 mg twice daily. This study has 2 components: a 4-week run-in period during which subjects are treated with prolonged-release fampridine and undergo subjective and objective assessments of walking ability, the results of which are used to determine who responded to study treatment, and an observational period, during which treatment responders will continue prolonged-release fampridine treatment. The subjects who do not meet the criteria to continue study treatment will be offered the opportunity to continue study participation but will not continue prolonged-release fampridine treatment.
|St Vincent's Hospital|
|Centre Hospitalier Universitaire de Liège|
|Dansk Multipel Sclerose Center|
|Nouvel Hôpital Civil, Clinique Neurologique|
|Ospedale San Raffaele|
|Centro Hospitalar de Coimbra, EPE|
|Royal Hallamshire Hospitals NHS Trust|
|Sheffield, United Kingdom|