Abstract |
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 > or =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.
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Authors | Charles H Adler, John N Caviness, Joseph G Hentz, Marlene Lind, Judy Tiede |
Journal | Movement disorders : official journal of the Movement Disorder Society
(Mov Disord)
Vol. 18
Issue 3
Pg. 287-293
(Mar 2003)
ISSN: 0885-3185 [Print] United States |
PMID | 12621632
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Benzhydryl Compounds
- Central Nervous System Stimulants
- Modafinil
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Topics |
- Adult
- Aged
- Benzhydryl Compounds
(adverse effects, therapeutic use)
- Central Nervous System Stimulants
(adverse effects, therapeutic use)
- Cross-Over Studies
- Disorders of Excessive Somnolence
(complications, diagnosis, drug therapy)
- Double-Blind Method
- Female
- Humans
- Male
- Modafinil
- Parkinson Disease
(complications, drug therapy)
- Psychiatric Status Rating Scales
- Severity of Illness Index
- Treatment Outcome
- Wakefulness
(drug effects)
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