BACKGROUND:Excessive daytime somnolence (EDS) commonly complicates Parkinson's disease (PD). The aetiology of EDS is probably multifactorial but is probably exacerbated by dopaminergic medications. Modafinil is a wake-promoting agent approved for use in narcolepsy, but it is often used to treat a variety of somnolent conditions. METHOD: A double blind, placebo controlled parallel design trial was conducted to assess the efficacy of modafinil (200-400 mg/day) for the treatment of EDS in PD. The primary efficacy measure was the Epworth Sleepiness (ES) scale score. Secondary efficacy points included the Unified Parkinson's Disease Rating Scale (UPDRS), the Fatigue Severity Scale, the Hamilton Depression Scale, and the multiple sleep latency test (MSLT). RESULTS: Of a total of 40 subjects (29 men, mean (SD) age 64.8 (11.3) years), randomised to modafinil or placebo, 37 completed the study. Modafinil failed to significantly improve ES scores compared with placebo (2.7 v 1.5 points improvement, respectively, p = 0.28). MSLT failed to improve with modafinil relative to placebo (-0.16 v -0.70, respectively, p = 0.14). UPDRS, global impressions, Fatigue Severity Scale, and Hamilton Depression Scale scores were unchanged. Adverse events were minimal. CONCLUSION:Modafinil failed to significantly improve EDS in PD compared with placebo. The drug did not alter motor symptoms in PD and was well tolerated.
RCT Entities:
BACKGROUND:Excessive daytime somnolence (EDS) commonly complicates Parkinson's disease (PD). The aetiology of EDS is probably multifactorial but is probably exacerbated by dopaminergic medications. Modafinil is a wake-promoting agent approved for use in narcolepsy, but it is often used to treat a variety of somnolent conditions. METHOD: A double blind, placebo controlled parallel design trial was conducted to assess the efficacy of modafinil (200-400 mg/day) for the treatment of EDS in PD. The primary efficacy measure was the Epworth Sleepiness (ES) scale score. Secondary efficacy points included the Unified Parkinson's Disease Rating Scale (UPDRS), the Fatigue Severity Scale, the Hamilton Depression Scale, and the multiple sleep latency test (MSLT). RESULTS: Of a total of 40 subjects (29 men, mean (SD) age 64.8 (11.3) years), randomised to modafinil or placebo, 37 completed the study. Modafinil failed to significantly improve ES scores compared with placebo (2.7 v 1.5 points improvement, respectively, p = 0.28). MSLT failed to improve with modafinil relative to placebo (-0.16 v -0.70, respectively, p = 0.14). UPDRS, global impressions, Fatigue Severity Scale, and Hamilton Depression Scale scores were unchanged. Adverse events were minimal. CONCLUSION:Modafinil failed to significantly improve EDS in PD compared with placebo. The drug did not alter motor symptoms in PD and was well tolerated.
Authors: M Littner; S F Johnson; W V McCall; W M Anderson; D Davila; S K Hartse; C A Kushida; M S Wise; M Hirshkowitz; B T Woodson Journal: Sleep Date: 2001-06-15 Impact factor: 5.849
Authors: T E Scammell; I V Estabrooke; M T McCarthy; R M Chemelli; M Yanagisawa; M S Miller; C B Saper Journal: J Neurosci Date: 2000-11-15 Impact factor: 6.167
Authors: X Drouot; S Moutereau; J P Nguyen; J P Lefaucheur; A Créange; P Remy; F Goldenberg; M P d'Ortho Journal: Neurology Date: 2003-08-26 Impact factor: 9.910
Authors: Richard J Castriotta; Strahil Atanasov; Mark C Wilde; Brent E Masel; Jenny M Lai; Samuel T Kuna Journal: J Clin Sleep Med Date: 2009-04-15 Impact factor: 4.062
Authors: Israt Jahan; Robert A Hauser; Kelly L Sullivan; Amber Miller; Theresa A Zesiewicz Journal: Neuropsychiatr Dis Treat Date: 2009-11-02 Impact factor: 2.570