Modafinil for fatigue in MS: a randomized placebo-controlled double-blind study.
Neurology
; 64(7): 1139-43, 2005 Apr 12.
Article
in En
| MEDLINE
| ID: mdl-15824337
ABSTRACT
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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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Benzhydryl Compounds
/
Fatigue
/
Central Nervous System Stimulants
/
Multiple Sclerosis
Type of study:
Clinical_trials
/
Etiology_studies
Limits:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Neurology
Year:
2005
Document type:
Article
Affiliation country:
France