A well-designed trial found no significant benefit across multiple testing domains.
These researchers randomized 121 MS patients with a baseline score of ≥4 (of a total of 7 points) on the Fatigue Severity Scale to receive modafinil (200 mg/day) or placebo for 8 weeks. Because the optimal fatigue rating scale remains controversial, the study also included six other fatigue and quality-of-life scales.
Mean improvement in the FSS score (the primary outcome) did not differ between the modafinil and placebo groups at 4 weeks, but a nonsignificant trend toward advantage with modafinil was evident at 8 weeks (mean score decline: modafinil, 0.75; placebo, 0.38; P=0.07) The drug showed no benefit on the six other related scales. Although exploratory, unadjusted assessments of 8-week improvement in cognitive performance showed a mar…
Reviewing Author
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)
DisclosuresConsultant/Advisory BoardAlexion Pharmaceuticals; Amgen; Astoria; Biogen; Bristol Myers Squibb; Celltrion; Genentech; Hoffmann-La Roche; Genzyme; EMD Serono; Immpact-Bio; Immunic Therapeutics; Kyverna; Lundbeck; Novartis; Sandoz; TG Therapeutics
Grant/Research SupportNational Institutes of Health; National Multiple Sclerosis Society; U.S. Department of Defense
Leadership Positions in Professional SocietiesConsortium of Multiple Sclerosis Centers (Treasurer)