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Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy

Publication ,  Conference
Fry,
Published in: Annals of Neurology
January 1998

Narcolepsy is a central nervous system disorder characterized by excessive daytime sleepiness and cataplexy. This placebocontrolled, double‐blind, randomized, parallel‐group, 18‐center study assessed the efficacy and safety of modafinil, a new wake‐promoting drug for treating sleepiness in narcolepsy. Subjects with narcolepsy (n = 283) received daily modafinil, 200 or 400 mg, or placebo, for 9 weeks, followed by an open‐label treatment period. Subjective sleepiness was measured with the Epworth Sleepiness Scale. Objective sleepiness was assessed with the Multiple Sleep Latency Test and the Maintenance of Wakefulness Test. Level of illness was measured with the Clinical Global Impression of Change. Modafinil significantly reduced all measures of sleepiness and was associated with significant improvements in level of illness. Medication‐related adverse expriences were few, dose‐dependent, and mostly rated mild to moderate. Modafinil taken once daily was a very well tolerated and effective wake‐promoting agent in the treatment of excessive daytime somnolence associated with narcolepsy. Modafinil demonstrated an excellent safety profile for up to 40 weeks of open‐label treatment and efficacy was maintained, suggesting that tolerance will not develop with long‐term use. Modafinil is a pharmacologically and clinically promising compound for the treatment of pathological daytime somnolence.

Duke Scholars

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Published In

Annals of Neurology

DOI

EISSN

1531-8249

ISSN

0364-5134

Publication Date

January 1998

Volume

43

Issue

1

Start / End Page

88 / 97

Publisher

Wiley

Related Subject Headings

  • Neurology & Neurosurgery
  • 3209 Neurosciences
  • 3202 Clinical sciences
  • 1109 Neurosciences
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Fry, . (1998). Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy. In Annals of Neurology (Vol. 43, pp. 88–97). Wiley. https://doi.org/10.1002/ana.410430115
Fry, Chin-Ho. “Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy.” In Annals of Neurology, 43:88–97. Wiley, 1998. https://doi.org/10.1002/ana.410430115.
Fry, Chin-Ho. “Randomized trial of modafinil for the treatment of pathological somnolence in narcolepsy.” Annals of Neurology, vol. 43, no. 1, Wiley, 1998, pp. 88–97. Crossref, doi:10.1002/ana.410430115.
Journal cover image

Published In

Annals of Neurology

DOI

EISSN

1531-8249

ISSN

0364-5134

Publication Date

January 1998

Volume

43

Issue

1

Start / End Page

88 / 97

Publisher

Wiley

Related Subject Headings

  • Neurology & Neurosurgery
  • 3209 Neurosciences
  • 3202 Clinical sciences
  • 1109 Neurosciences
  • 1103 Clinical Sciences