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Neurology. 2005 Apr 12;64(7):1139-43.
Stankoff B, Waubant E, Confavreux C, Edan G, Debouverie M, Rumbach L,
Moreau T, Pelletier J, Lubetzki C, Clanet M; French Modafinil Study Group.
Federation de Neurologie, Hopital de la Salpetriere, AP-HP, Paris, France.
Modafinil for fatigue in MS: a randomized placebo-controlled double-blind
study.
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.
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