Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial.
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.
Orbis Medical Center, Sittard-Geleen, the Netherlands r.hupperts@orbisconcern.nl.
Raymond
R
Hupperts
Institute of Neuroscience and Physiology, The Sahlgrenska Academy, Gothenburg, Sweden.
Jan
J
Lycke
Queen Elizabeth II Health Sciences Centre, Halifax, Canada.
Christine
C
Short
Hospital San Camillo Forlanini, Rome, Italy.
Claudio
C
Gasperini
Biogen, Maidenhead, UK.
Manjit
M
McNeill
Biogen, Cambridge, MA, USA.
Rossella
R
Medori
Biogen, Maidenhead, UK.
Agata
A
Tofil-Kaluza
Excel Scientific Solutions, Southport, CT, USA.
Maria
M
Hovenden
Biogen, Cambridge, MA, USA.
Lahar R
LR
Mehta
Biogen, Cambridge, MA, USA.
Jacob
J
Elkins
D015761:4-Aminopyridine / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D051346:Mobility Limitation; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000503:physiopathology; D004856:Postural Balance; D026902:Potassium Channel Blockers / Q000627:therapeutic use*; D016138:Walking
D003692:Delayed-Action Preparations; D026902:Potassium Channel Blockers; D015761:4-Aminopyridine
Fampridine; balance; multiple sclerosis; randomised clinical trial; walking