Effect of Dalfampridine on cognition, gait and fatigue in patients with multiple sclerosis: a randomized placebo-controlled study.

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.