Portal de Periódicos da CAPES

Modafinil for fatigue in MS

2005; Lippincott Williams & Wilkins; Volume: 64; Issue: 7 Linguagem: Inglês

10.1212/01.wnl.0000158272.27070.6a

1526-632X

Bruno Stankoff, Emmanuelle Waubant, Christian Confavreux, Gilles Edan, Marc Debouverie, L. Rumbach, T. Moreau, Jean Pelletier, Catherine Lubetzki, M. Clanet,

Peripheral Neuropathies and Disorders

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.