Objective: This study, an open-labeled trial, was aimed to assess the efficacy and safety of selegiline on the treatment of EDS in PD patients.
Background: Excessive Daytime Sleepiness (EDS) is common in Parkinson’s disease (PD) and might be influenced by treatment of various dopaminergic therapies.
Method: It is a multi-center study, one hundred and forty-one subjects were enrolled during December 2019 and October 2020. 121 PD patients completed this 8-week study. Selegiline was initiated at a dosage of 5 mg/day, and was gradually titrated to 10 mg once daily for the next 7 weeks if tolerated. The severity of EDS was evaluated by Epworth Sleepiness Scale (ESS) at baseline, week 3 and week 8. Changes of motor complications, sleep quality and Quality-of-Life were also assessed in patients with PD.
Clinical trial Number: JD-LK-2019-103-02
Results: At primary end-points, ESS scores were significantly decreased in PD patients after the treatment of selegiline at 8 weeks (P<0.001). Abnormal sleep tendency was alleviated on ESS scale. For the secondary outcomes, the scores of Parkinson’s disease sleep scale-2 (PDSS-2) and Parkinson’s Disease Quality-of-Life Questionnaire 39 (PDQ-39) were also improved after the treatment. The severity of motor fluctuation was also improved (P=0.037), while the proportion of dyskinesia (commonly encountered AEs) was not significantly increased compared with that at baseline.
Conclusion: Participants showed an improvement in EDS and good tolerability with selegiline treatment. This study is the first study on evaluating the efficacy and safety of selegiline on the treatment of daytime sleepiness in PD patients.
References: Bliwise DL, Trotti LM, Juncos JJ, Factor SA, Freeman A, Rye DB. Daytime REM sleep in Parkinson’s disease. Parkinsonism Relat Disord 2013;19:101-103. Hublin C, Partinen M, Heinonen EH, Puukka P, Salmi T. Selegiline in the treatment of narcolepsy. Neurology 1994;44:2095-2101. Heinonen EH, Rinne UK, Tuominen J. Selegiline in the treatment of daily fluctuations in disability of parkinsonian patients with long-term levodopa treatment. Acta Neurol Scand Suppl 1989;126:113-118. Mizuno Y, Hattori N, Kondo T, et al. A Randomized Double-Blind Placebo-Controlled Phase III Trial of Selegiline Monotherapy for Early Parkinson Disease. Clin Neuropharmacol 2017;40:201-207.
To cite this abstract in AMA style:
JR. Zhang, JP. Chen, J. Li, J. Li, CJ. Mao, CF. Liu. Improved Excessive Daytime Sleepiness with Selegiline in patients with Parkinson’s Disease: An Open Trial [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/improved-excessive-daytime-sleepiness-with-selegiline-in-patients-with-parkinsons-disease-an-open-trial/. Accessed May 14, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/improved-excessive-daytime-sleepiness-with-selegiline-in-patients-with-parkinsons-disease-an-open-trial/