• Neurology Clinical Trials
• Demyelinating Diseases

• Neurology
• Neurology Clinical Trials
• Demyelinating Diseases

Prolonged release (PR)-fampridine treatment resulted in sustained and clinically meaningful improvement in walking ability and balance throughout a 6-month treatment period in individuals with multiple sclerosis (MS). The Exploratory Study to Assess the Effect of Fampridine (BIIB041) on Walking Ability and Balance in Participants With Multiple Sclerosis study [MOBILE; NCT01597297; Hupperts R et al. ACTRIMS/ECTRIMS 2014 (poster P922)] evaluated the effect of PR-fampridine on walking ability, dynamic and static balance, and subjective impressions of well-being. Raymond Hupperts, MD, Orbis Medical Center, Sittard-Geleen, the Netherlands, presented the findings in a poster session.

Maintaining mobility is among the greatest concerns for patients with MS [Sutliff MH. Curr Med Res Opin. 2010]. PR-fampridine was approved to improve walking in MS based on the results of 2 pivotal trials [Goodman AD et al. Ann Neurol. 2010; Goodman AD et al. Lancet. 2009] that demonstrated consistent improvements on the Timed 25-Foot Walk (T25FW). The T25FW, however, may not fully assess all of the domains that control walking ability, including balance [Nogueira LA et al. Mult Scler Int. 2013].

MOBILE was a randomized, double-blind, multicenter, placebo-controlled, exploratory 24-week phase 2 study conducted at 24 sites in 6 countries. Patients (n = 132) aged 18 to 70 years, with progressive and relapsing MS and an Expanded Disability Status Scale (EDSS) score of 4.0 to 7.0, were randomly assigned (1:1) to PR-fampridine 10 mg BID (n = 68) or placebo (n = 64) for 24 weeks. Outcome measures included walking ability assessment using the 12-item Multiple Sclerosis Walking Scale (MSWS-12) and Patient Global Impression of Change (PGIC); mobility and balance assessment using the Timed Up and Go (TUG) test and Berg Balance Scale (BBS); and subjective impression of well-being assessment using the Multiple Sclerosis Impact Scale (MSIS-29), physical subscale (PHYS), and EuroQoL-5 Dimension 5-level instrument (EQ-5D-5L). Safety and tolerability were assessed by monitoring adverse events (AEs).

Mean age of the patients was 49.8 years; 54% were women. The mean EDSS score was 5.7. Baseline to week 24 improvements in the MSWS-12, TUG test, BBS, and MSIS-29 PHYS were greater following treatment with PR-fampridine compared with placebo. Benefits declined by the week 26 visit following discontinuation of treatment at week 24.

More patients treated with PR-fampridine vs placebo reported improvement on the PGIC at the week 2 visit: 31 patients (46%) for PR-fampridine vs 16 (26%) for placebo. No apparent differences between treatment groups were observed in the EQ-5D-5L utility index. The cumulative percentage of patients with a mean improvement in the MSWS-12 score and TUG test was greater in the PR-fampridine-treated patients compared with the placebo group.

Safety findings were consistent with the known safety profile of PR-fampridine. The number of patients who discontinued (PR-fampridine, n = 13; placebo, n = 12) was similar. AEs were the main reason for discontinuation in both groups (PR-fampridine, n = 7; placebo, n = 5). No seizures were reported, and serious AEs were reported by fewer patients treated with PR-fampridine (2/68; 3%) compared with placebo (5/64; 8%). The common AEs were nasopharyngitis and urinary tract infection.

In this study, PR-fampridine improved a broad range of objective and patient-reported measures of walking ability. An ongoing phase 3 study will seek to confirm these findings.

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