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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.
Address correspondence and reprint requests to Dr. Bruno Stankoff, Centre d’Investigation Clinique, Hôpital de la Salpêtrière, 47 boulevard de l’Hôpital, 75651 Paris cedex 13, France; e-mail: bruno.stankoff{at}psl.ap-hop-paris.fr
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.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the April 12 issue to find the title link for this article.
Editorial, see page 1111
See also page 1267
*These authors contributed equally to this work.
Members of the French Modafinil Study Group are listed in the Appendix.
Supported by Cephalon, which played a role in conduct of the study and collection of data.
Received July 14, 2004. Accepted in final form January 25, 2005.
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