Abstract Details

Title Prolonged-Release Fampridine Treatment and Walking Ability and Balance in Patients with Multiple Sclerosis: Results of the Randomized, Double-Blind MOBILE Study

Topic Multiple Sclerosis

Presentation(s) (-)

Poster/Presentation
Number 010

Objective

Background Walking impairment negatively impacts QoL and is one of the most commonly reported disabilities among MS patients.

Design/Methods MOBILE was a randomized, double-blind, multicenter, placebo-controlled study. Patients (18-70 years) with progressive or relapsing-remitting MS (revised McDonald criteria) and EDSS score of 4-7 were treated with PR-fampridine 10mg tablets 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, Berg Balance Scale (BBS), 29-item MS impact scale (MSIS-29), and the EuroQol (EQ-5D-5L). MOBILE was designed to explore the effects of PR-fampridine on a range of walking-related endpoints. Post hoc statistical testing compared multiple thresholds of improvement between treatment groups for each of MSWS-12 and TUG using a logistic regression adjusted for baseline.

Results 132 subjects were randomized at 24 sites worldwide. Over the 24-week study period, a higher proportion of subjects randomized to PR-fampridine vs. placebo experienced clinically meaningful improvements on the MSWS-12 (>=8 point mean improvement): 48.5% vs. 28.1% (P=0.015); and TUG speed (>=15% mean improvement): 47.1% vs. 30.2% (P=0.026), respectively. PR-fampridine treatment also resulted in greater (median) improvements from baseline on the MSWS-12 (-6.92 vs -2.89), TUG speed (12.26% vs 3.49%), BBS (2.93 vs 1.71) and MSIS-29 physical subscale (-4.96 vs -2.19) versus placebo. Safety findings were similar to previous studies.

Conclusions PR-fampridine treatment resulted in sustained, clinically meaningful improvement in walking ability and balance over the 6-month treatment period. These findings extend prior Phase 3 results to a longer treatment period and a broader range of objective and patient-reported measures of walking ability.

Authors/Disclosures
Jan N. Lycke, MD	Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Lycke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Lycke has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GeNeuro. The institution of Dr. Lycke has received research support from Sanofi.
Christine Short	No disclosure on file
Claudio Gasperini, MD	Dr. Gasperini has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche, Merck, Genzyme, Novartis,Bayer, Teva, Almirall.
Laura R. Gwyn (University of Michigan)	Mrs. Gwyn has nothing to disclose.
	No disclosure on file
Rossella Medori, MD (Biogen Idec Internaitonal GmbH)	No disclosure on file
Lahar R. Mehta, MD	Dr. Mehta has received personal compensation for serving as an employee of Amylyx Pharmaceuticals.
Jacob S. Elkins, MD	No disclosure on file
Anne H. Cross, MD, FAAN (Washington University School of Medicine)	Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech / F. Hoffman la Roche. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb . Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Cross has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Consortium of MS Centers. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. The institution of Dr. Cross has received research support from Genentech. Dr. Cross has received intellectual property interests from a discovery or technology relating to health care.

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