MODAFINIL - A DOUBLE-BLIND MULTICENTRIC STUDY

Modafinil is a central putative alpha-1 postsynaptic agonist with vigi lance-promoting properties. Fifty narcoleptics (33 male and 17 female) participated in a multicentric study aimed at assessing the effects o f the compound on night sleep, feeling on awakening, excessive daytime sleepiness and cataplexy. Modafinil was administered in a double-blin d cross-over design at a daily dosage of 300 mg versus placebo. The du ration of the study was 12 weeks, including a 2-week ''run in'' period with placebo, a first 4-week treatment period with either modafinil o r placebo, a 2-week wash-out period with placebo and a second 4-week t reatment 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 ni ghts 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 o f night sleep, but a reduction of daytime sleepiness and sleep. Feelin g on awakening was not modified. An overall benefit was noted by physi cians as well as by patients. MWT disclosed a positive effect of modaf inil on excessive daytime sleepiness. Cataplexy was not modified.