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Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease
Author(s) -
Adler Charles H.,
Caviness John N.,
Hentz Joseph G.,
Lind Marlene,
Tiede Judy
Publication year - 2003
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.10390
Subject(s) - modafinil , placebo , epworth sleepiness scale , excessive daytime sleepiness , crossover study , medicine , anesthesia , psychology , somnolence , parkinson's disease , randomized controlled trial , clinical global impression , adverse effect , psychiatry , sleep disorder , disease , polysomnography , insomnia , alternative medicine , apnea , pathology
We assessed the safety and efficacy of modafinil for the treatment of excessive daytime sleepiness in patients with Parkinson's disease (PD). This was a single‐site, randomized, double‐blind, placebo‐controlled crossover study of 21 PD patients having an Epworth Sleepiness Scale (ESS) score ≥10. They received either placebo or modafinil 200 mg/day for 3 weeks, followed by a washout week, then the alternate treatment for 3 weeks. The ESS data demonstrated a carryover effect, so the changes from baseline ESS scores were compared between the two treatments for period 1 only. The ESS scores for the placebo group went from 16.0 ± 4.2 (mean ± SD) to 17.0 ± 5.1 and for the modafinil group went from 17.8 ± 4.2 to 14.4 ± 5.7 ( P = 0.039). There was no significant carryover effect for any other measure. The patient Clinical Global Impression of Change (+3 to −3) improved by 0.75 on modafinil compared with 0.15 for placebo ( P = 0.07). A total of 7 of 20 (35%) of the patients reported some improvement on modafinil but not placebo. There was no significant improvement or worsening of the UPDRS subscores I–III, Timed Tap test, or time on . Vital signs, electrocardiograms, and lab tests were unchanged. Modafinil was very well tolerated. Our data demonstrate that, in a small sample size, administration of 200 mg/day of modafinil was associated with few side effects and was modestly effective for the treatment of excessive daytime sleepiness in patients with PD.