Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial

Mult Scler. 2016 Feb;22(2):212-21. doi: 10.1177/1352458515581436. Epub 2015 Apr 28.

Abstract

Background: Mobility impairment is a common disability in MS and negatively impacts patients' lives.

Objective: Evaluate the effect of prolonged-release (PR) fampridine (extended-release dalfampridine in the United States) on self-assessed walking disability, dynamic/static balance and safety in patients with MS.

Methods: MOBILE was a randomised, double-blind, exploratory, placebo-controlled trial. Patients with progressive/relapsing-remitting MS and Expanded Disability Status Scale score of 4.0-7.0 were treated with PR-fampridine or placebo twice daily for 24 weeks. Efficacy endpoints included change from baseline in the 12-item MS Walking Scale (MSWS-12), Timed Up and Go (TUG) test and Berg Balance Scale (BBS).

Results: 132 patients were randomised at 24 sites in six countries. PR-fampridine therapy resulted in greater median improvements from baseline in MSWS-12 score, TUG speed and BBS total score versus placebo over 24 weeks. A higher proportion of patients receiving PR-fampridine versus placebo experienced significant improvements at MSWS-12 improvement thresholds ⩾7 (p = 0.0275), ⩾8 (p = 0.0153) and ⩾9 points (p = 0.0088) and TUG speed thresholds ⩾10% (p = 0.0021) and ⩾15% (p = 0.0262). PR-fampridine was well tolerated.

Conclusions: PR-fampridine therapy resulted in early and sustained improvements in broad measures of walking and balance over six months.

Keywords: Fampridine; balance; multiple sclerosis; randomised clinical trial; walking.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 4-Aminopyridine / therapeutic use*
  • Delayed-Action Preparations
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mobility Limitation
  • Multiple Sclerosis / drug therapy*
  • Multiple Sclerosis / physiopathology
  • Postural Balance*
  • Potassium Channel Blockers / therapeutic use*
  • Walking*

Substances

  • Delayed-Action Preparations
  • Potassium Channel Blockers
  • 4-Aminopyridine