Dalfampridine in the treatment of primary fatigue in patients with multiple sclerosis: a randomized clinical trail.

ABSTRACT

INTRODUCTION: Fatigue is a highly prevalent debilitating symptom among patients with multiple sclerosis (PwMS), which markedly affects the quality of life. The present study aimed to evaluate the effect of extended-release fampridine on fatigue in PwMS. METHODS: This was a randomized, double-blind clinical trial on 77 PwMS with a complaint of fatigue, aged over 18 years old, randomized to extended-release fampridine (n = 44) or placebo (n = 35) for 12 weeks. Fatigue and motor function were assessed at baseline and end point. RESULTS: A total of 88 patients were recruited, of whom 77 were analyzed. 80.5% were female, with a median age of 38. 87% were diagnosed with relapsing-remitting MS (RRMS) with a median disease duration of 96 months. Fingolimod (37.7%) was considered the most frequently used DMT, followed by ani-CD20s (32.5%). The total median MFIS score was 43.5 and 37 in the fampridine and placebo groups which were not significantly different (p > 0.05). After 12 weeks, the total MFIS improved in both groups compared to the baseline, which was significant in the active group (p = 0.04). However, the final end point total MFIS was still comparable between the two groups (p = 0.11). CONCLUSION: The present study revealed a positive short-term effect of extended-release fampridine on MFIS in PwMS. However, this effect was not significantly superior to the placebo.