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Modafinil: a double-blind multicentric
study.
Billiard M, Besset A, Montplaisir J,
Laffont F, Goldenberg F, Weill JS, Lubin S.
Service de Neurologie B,
Hopital Gui de Chauliac,
Montpellier, France
Sleep 1994 Dec;17(8 Suppl):S107-12
ABSTRACT
Modafinil is a central putative
alpha-1 postsynaptic agonist with vigilance-promoting properties. Fifty
narcoleptics (33 male and 17 female) participated in a multicentric study
aimed at assessing the effects of the compound on night sleep, feeling on
awakening, excessive daytime sleepiness and cataplexy. Modafinil was
administered in a double-blind cross-over design at a daily dosage of 300 mg
versus placebo. The duration of the study was 12 weeks, including a 2-week
"run in" period with placebo, a first 4-week treatment period with
either modafinil or placebo, a 2-week wash-out period with placebo and a
second 4-week treatment period with either placebo or modafinil. Daily
evaluation was based on a sleep log, visual analog scales, a sleep
questionnaire and a clinical global index. Sleep laboratory evaluation took
place on nights 1, 28, 42 and 70. It included 1 night of polysomnography
preceded by a questionnaire on therapeutic and side effects, and a maintenance
of wakefulness test (MWT). Sleep logs did not show any modification of night
sleep, but a reduction of daytime sleepiness and sleep. Feeling on awakening
was not modified. An overall benefit was noted by physicians as well as by
patients. MWT disclosed a positive effect of modafinil on excessive daytime
sleepiness. Cataplexy was not modified.
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