Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease

Charles Howard Adler, John Nathaniel Caviness, Joseph G. Hentz, Marlene Lind, Judy Tiede

Research output: Contribution to journalArticle

232 Citations (Scopus)

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 ≥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.

Original languageEnglish (US)
Pages (from-to)287-293
Number of pages7
JournalMovement Disorders
Volume18
Issue number3
DOIs
StatePublished - Mar 1 2003

Fingerprint

Parkinson Disease
Placebos
Vital Signs
modafinil
Sample Size
Cross-Over Studies
Electrocardiography
Therapeutics
Safety

Keywords

  • Excessive daytime sleepiness
  • Modafinil
  • Parkinson's disease

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease. / Adler, Charles Howard; Caviness, John Nathaniel; Hentz, Joseph G.; Lind, Marlene; Tiede, Judy.

In: Movement Disorders, Vol. 18, No. 3, 01.03.2003, p. 287-293.

Research output: Contribution to journalArticle

@article{c8e5496fcd7a4e3bbb35ef04eecf8191,
title = "Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease",
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 ≥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.",
keywords = "Excessive daytime sleepiness, Modafinil, Parkinson's disease",
author = "Adler, {Charles Howard} and Caviness, {John Nathaniel} and Hentz, {Joseph G.} and Marlene Lind and Judy Tiede",
year = "2003",
month = "3",
day = "1",
doi = "10.1002/mds.10390",
language = "English (US)",
volume = "18",
pages = "287--293",
journal = "Movement Disorders",
issn = "0885-3185",
publisher = "John Wiley and Sons Inc.",
number = "3",

}

TY - JOUR

T1 - Randomized trial of modafinil for treating subjective daytime sleepiness in patients with Parkinson's disease

AU - Adler, Charles Howard

AU - Caviness, John Nathaniel

AU - Hentz, Joseph G.

AU - Lind, Marlene

AU - Tiede, Judy

PY - 2003/3/1

Y1 - 2003/3/1

N2 - 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.

AB - 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.

KW - Excessive daytime sleepiness

KW - Modafinil

KW - Parkinson's disease

UR - http://www.scopus.com/inward/record.url?scp=0037355884&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037355884&partnerID=8YFLogxK

U2 - 10.1002/mds.10390

DO - 10.1002/mds.10390

M3 - Article

C2 - 12621632

AN - SCOPUS:0037355884

VL - 18

SP - 287

EP - 293

JO - Movement Disorders

JF - Movement Disorders

SN - 0885-3185

IS - 3

ER -