Prolonged Release Fampridine Effect on Walking Ability, Balance in MS

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)-218MS205

• IRAS ID

  107532

• Contact name

  Eli Silber

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2012-000368-90

• ISRCTN Number

  xx

• Research summary

  This study will assess the effect of prolonged-release fampridine 10 mg twice daily on Multiple Sclerosis patients?? self-assessed walking disability by using the Multiple Sclerosis Walking Scale-12 (MSWS-12), and on balance by means of the Timed Up and Go (TUG) and the Berg Balance Scale (BBS), to further support prolonged-release fampridine??s impact on overall walking disability. Prolonged release fampridine is approved for improvement of walking in adult patients with multiple sclerosis (MS) with walking disability.Approximately 120 subjects from approximately 20 sites around the world are planned to participate. Subjects will be randomised (like flipping a coin) into 2 treatment groups: Group 1 (60 subjects) will receive prolonged-release fampridine 10 mg twice daily (every 12 hours) for up to 24 weeks. Group 2 (60 subjects) will receive matched placebo (dummy drug) twice daily (every 12 hours) for up to 24 weeks. The duration of subject participation in this study will be approximately 28 weeks, which will include a 14-day screening period, a 24-week double-blind treatment period, and a follow-up visit 14-days after the last dose.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  12/LO/0985

• Date of REC Opinion

  27 Jun 2012

• REC opinion

  Favourable Opinion