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

• Published in: Multiple sclerosis Vol. 22; no. 2; pp. 212 - 221
• Main Authors: Hupperts, Raymond, Lycke, Jan, Short, Christine, Gasperini, Claudio, McNeill, Manjit, Medori, Rossella, Tofil-Kaluza, Agata, Hovenden, Maria, Mehta, Lahar R, Elkins, Jacob
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.02.2016
• Subjects: 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; balance; randomised clinical trial; Fampridine; walking; multiple sclerosis
• ISSN: 1352-4585; 1477-0970
• DOI: 10.1177/1352458515581436

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.