Multiple sclerosis and related disorders · 2026
Effect of Dalfampridine on cognition, gait and fatigue in patients with multiple sclerosis: a randomized placebo-controlled study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Abdeldayem Mai Mohamed Elsayed, Abdelnasser Azza, Khalil Salma Hamed, Hamid Eman, Abousteit Alaa Mohamed, Abushady Eman Mones, Shalash Ali
Аннотация
BACKGROUND: Inconsistent results on dalfampridine in RRMS may reflect variability in patient characteristics.
OBJECTIVE: This randomized, double-blind, placebo-controlled trial was preregistered at ClinicalTrials.gov (NCT05730738), aimed to investigate the effects of dalfampridine on gait, cognition, and fatigue in patients with mild to moderate symptoms.
METHODS: Patients with RRMS who had an EDSS score of ≤5.5 and a 25-Foot Walk Test (25FWT) time of ≥ 4 seconds, and who reported fatigue and cognitive impairment, were randomized to receive either dalfampridine or placebo for 3 months. Patients were assessed by the 25FWT, Berg Balance Test, Hauser Ambulation Index, the Brief International Cognitive Assessment, Montreal Cognitive Assessment, Frontal Assessment Battery, and the Modified Fatigue Impact Scale.
RESULTS: Among 100 participants allocated to the study, 89 completed the follow-up. Compared with the placebo group, the dalfampridine group showed significantly lower pyramidal system impairment and disability (p = 0.006) and better cognitive performance (p = 0.04), with comparable side-effect profiles at the 3-month follow-up. There was a significant reduction in fatigue at follow-up compared to baseline (p=0.006).
CONCLUSION: The current study demonstrated the positive effect of dalfampridine on cognitive impairment and fatigue in patients with mild to moderate symptoms. However, further RCTs are warranted to confirm its long-term benefits.
OBJECTIVE: This randomized, double-blind, placebo-controlled trial was preregistered at ClinicalTrials.gov (NCT05730738), aimed to investigate the effects of dalfampridine on gait, cognition, and fatigue in patients with mild to moderate symptoms.
METHODS: Patients with RRMS who had an EDSS score of ≤5.5 and a 25-Foot Walk Test (25FWT) time of ≥ 4 seconds, and who reported fatigue and cognitive impairment, were randomized to receive either dalfampridine or placebo for 3 months. Patients were assessed by the 25FWT, Berg Balance Test, Hauser Ambulation Index, the Brief International Cognitive Assessment, Montreal Cognitive Assessment, Frontal Assessment Battery, and the Modified Fatigue Impact Scale.
RESULTS: Among 100 participants allocated to the study, 89 completed the follow-up. Compared with the placebo group, the dalfampridine group showed significantly lower pyramidal system impairment and disability (p = 0.006) and better cognitive performance (p = 0.04), with comparable side-effect profiles at the 3-month follow-up. There was a significant reduction in fatigue at follow-up compared to baseline (p=0.006).
CONCLUSION: The current study demonstrated the positive effect of dalfampridine on cognitive impairment and fatigue in patients with mild to moderate symptoms. However, further RCTs are warranted to confirm its long-term benefits.