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.
Stankoff
B
B
Fédération de Neurologie, Hôpital de la Salpêtrière, AP-HP, Paris, France. bruno.stankoff@psl.ap-hop-paris.fr
Waubant
E
E
Confavreux
C
C
Edan
G
G
Debouverie
M
M
Rumbach
L
L
Moreau
T
T
Pelletier
J
J
Lubetzki
C
C
Clanet
M
M
D000328:Adult; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D009103:Multiple Sclerosis / Q000150:complications*; D010919:Placebos; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D016896:Treatment Outcome
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D010919:Placebos; D000077408:Modafinil