B. Stankoff, MD, PhD, E. Waubant, MD, PhD, C. Confavreux, MD, G. Edan, MD, M. Debouverie, MD, L. Rumbach, MD, T. Moreau, MD, PhD, J. Pelletier, MD, PhD, C. Lubetzki, MD, PhD, M. Clanet, MD, PhD and French Modafinil Study Group.
Modafinil for fatigue in MS: A randomized placebo-controlled double-blind study. Neurology 2005; 64: 1139-1143.
From the Fédération de Neurologie (Drs. Stankoff and Lubetzki), Centre d’Investigation Clinique (Drs. Stankoff and Waubant), Hôpital de la Salpêtrière, AP-HP, Paris, France; Services de Neurologie, CHU de Lyon (Dr. Confavreux), Rennes (Dr. Edan), Nancy (Dr. Debouverie), Besançon (Dr. Rumbach), Dijon (Dr. Moreau), and Marseille (Dr. Pelletier); Fédération de Neurologie (Dr. Clanet), CHU de Toulouse, France; and UCSF MS Center (Dr. Waubant), San Francisco, CA.
Objective: To assess whether modafinil, a wakefulness-promoting agent, is useful for fatigue in patients with multiple sclerosis (MS).
Methods: Patients with MS with stable disability, and a baseline score of 45 or more on the Modified Fatigue Impact Scale (MFIS), were eligible for the 5-week randomized, double-blind, placebo-controlled, parallel group study. The initial daily dose of modafinil was 200 mg for 1 week. Depending on tolerance, the dose was increased by 100 mg every week up to 400 mg/day and remained unchanged between day 21 and day 35. The primary outcome variable was the change of MFIS score at day 35.
Results: A total of 115 patients with MS were enrolled in the study and in the intention to treat analysis. The mean MFIS score at baseline was 63 ± 9 in the placebo group and 63 ± 10 in the modafinil group. MFIS scores improved between day 0 and day 35 in both placebo-treated and modafinil-treated groups, but no significant difference was detected between the two groups. There was no major safety concern.
Conclusions: There was no improvement of fatigue in patients with multiple sclerosis treated with modafinil vs placebo according to the Modified Fatigue Impact Scale.