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Objective: The aim of this study was to explore the modification of gait parameters, in relation with patient-reported outcomes, following a treatment by prolonged release(PR)-Fampridine, among patients with MS. Methods: In this crossover, double-blind trial, patients with MS (EDSS ≤6) were first tested for responder status during a 4-week run-in period. Patients were considered responders if they improved their 25-foot timed walk test (25f-TWT) by at least 10% and improved their perceived walking capacity (Multiple Sclerosis Walking Scale-12 items (MSWS-12)). Responders were randomized to PR-fampridine (10mg, 2 times per day) or placebo for a 6-week period. After the end of this first period, they underwent a 2-week washout period before being given the other treatment. Participants were assessed before and after both treatments. Instrumented three-dimension gait analysis was used to assess gait impairments. Kinematic, kinetic and energetic parameters were recorder. phase. Six-minute walk test (6MWT) and 25f-TWT were used to assess walking capacity on long and short distances, respectively. Patient-reported outcomes were used to evaluate perceived fatigue (Modified Fatigue Impact Scale (MFIS)), perceived walking capacity (MSWS-12) and quality of life (SEP-59). For each variable, a repeated measures ANCOVA was applied, with the treatment being the explicative variable and the within-subject differences between baselines (prePR-fampridine and prePlacebo) being the covariate. Results: 24 patients were included (12 women; median EDSS 4.25 [4-5]; mean age 46±10 years; maximal walking speed 0.93±0.38m.s-1; baseline 6MWT: 295.7±126m). The only kinetic parameter significantly modified was external work (-0.039 J.kg-1.m-1, i.e. 9%, p=0.02). Regarding kinematic parameters, K4 of the dominant limb was significantly increased by the intervention (+5.3°; p=0.02). Step length was also statistically, but not clinically significantly, reduced in both sides (-1.7 cm; p=0.002). A trend toward an improvement was observed in the 6MWT (+17.6m [-2.5 m - +37.6 m], p=0.07). No statistically significant differences were found in other walking tests and patient-reported outcomes. Conclusions: PR-Fampridine increases knee flexion during swing phase and lowers external work. Whether these changes are related to clinically meaningful improvements in walking capacity and other functional parameters is unknown. The research was funded by BIOGEN
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Valet, M., El Sankari, S., Van Pesch, V., Lejeune, T., & Stoquart, G. (2019). Effects of PR-Fampridine on gait pattern and patient-reported outcomes: A cross-over, randomized, placebo-controlled trial. ECTRIMS 2019, Stockholm. https://hdl.handle.net/2078.5/213738