Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinson's disease: Clinical trials, pharmacology and treatment
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To study the effects of Rasagiline on sleep disturbances measured by polysomnographic (PSG) evaluation of sleep efficacy and secondary measures as other sleep variables, sleep quality, daytime sleepiness, cognitive function and depression as assessed by standardized scales.
Background: Sleep disturbances are one of the most frequent non-motor symptoms in patients with Parkinson’s disease (PD) and have an immense negative impact on quality of life. In PD problems with sleep initiation and maintaining of sleep are most common. Rasagiline was reported to cause less sleep disruption in PD patients than placebo but polysomnographic trials on its effect on sleep are missing.
Methods: Aim of this study was to evaluate the effect of Rasagiline on sleep disturbances in PD measured by polysomnographic (PSG) evaluation of sleep efficacy and other sleep parameters as well as sleep quality and daytime sleepiness as assessed e.g. by the Parkinson’s disease Sleep Scale – 2 (PDSS-2), Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS). 30 patients were treated with placebo for 2 weeks (placebo run-in phase) and subsequently switched to Rasagiline (1mg / day) or placebo for 8 weeks in a placebo-controlled, double-blind trial design with a randomization ratio of 2:1 (Rasagiline vs. placebo). Inclusion criteria were PD patients according to UK PD brain bank criteria, Hoehn & Yahr stadium I-III, age 50 – 85 with relevant sleeping disorder as assessed by the PSQI (> 5 points).
Results: 30 PD patients were included (age 70 ± 6.9 years; 16 male; H & Y 2.0 ± 0.8). Sleep efficacy was significantly improved (SE % 62.1 ± 11.9 vs. 70.6 ± 13.9; p = 0,024) in the Rasagilin group. Light sleep (N1 % 22 ± 12.2 vs. 17.2 ± 9.8; p = 0.036) and waking time (206.2 ± 72.9 vs. 175.8 ± 74.3; p = 0.048) and also arousals were significantly decreased (49.9 ± 19.1 vs. 43.6 ± 18.1; p = 0.019) and there was a trend towards a consecutive increase of percentage of slow wave sleep and REM sleep (n.s.). Daytime sleepiness (ESS) significantly improved (9 ± 4.8 vs. 8.1 ± 4.7, p = 0.011). Rasagiline was well tolerated and no relevant adverse events were reported.
Conclusions: Rasagilin is well tolerated and effective in improving sleep in PD.
To cite this abstract in AMA style:
W. Schrempf, M. Fauser, K. Otto, M. Wienecke, C. Ossig, S. Brown, A. Maass, M.D. Brandt, U. Schwanebeck, X. Graehlert, H. Reichmann, A. Storch. Rasagiline treatment for sleep disorders in Parkinson’s disease (RaSPar) – Double-blinded, randomized, placebo-controlled, placebo run-in-phase, polysomnography clinical trial [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/rasagiline-treatment-for-sleep-disorders-in-parkinsons-disease-raspar-double-blinded-randomized-placebo-controlled-placebo-run-in-phase-polysomnography-clinical-trial/. Accessed June 14, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/rasagiline-treatment-for-sleep-disorders-in-parkinsons-disease-raspar-double-blinded-randomized-placebo-controlled-placebo-run-in-phase-polysomnography-clinical-trial/