Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease.
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.
Adler
Charles H
CH
Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.
Caviness
John N
JN
Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.
Hentz
Joseph G
JG
Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.
Lind
Marlene
M
Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.
Tiede
Judy
J
Parkinson's Disease and Movement Disorders Center, Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA.
D000328:Adult; D000368:Aged; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D006970:Disorders of Excessive Somnolence / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000077408:Modafinil; D010300:Parkinson Disease / Q000150:complications* / Q000188:drug therapy; D011569:Psychiatric Status Rating Scales; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D000077408:Modafinil