Treatment with Rasagiline Improves the Quality of Sleep in Patients with Parkinson's Disease: Results of the Rasagiline Effect on Sleep Trial (REST) (S52.006)

Abstract

Objective: To evaluate the impact of rasagiline treatment on sleep disturbances in Parkinson Disease. Background Sleep dysfunction in PD is common affecting some 60–98% of patients. Sleep disorders include excessive daytime sleepiness, sleep attacks, advanced sleep phase syndrome, nocturnal awakenings, and REM sleep behaviour disorder – each having a significant impact on patient quality of life. Design/Methods: This was an open-label, multi-center, single-arm study in patients with PD who were considered suitable for treatment with rasagiline as monotherapy or adjunct therapy (0.5 or 1.0 mg once daily per Canadian label). Subjects were assessed at baseline and after 2 months of treatment using the Parkinson9s Disease Sleep Scale (PDSS) to assess overall sleep quality and Epworth Sleepiness Scale (ESS) to assess daytime sleepiness. Results: 110 PD patients were treated with rasagiline (mean age 67 years; disease duration 4.3 years) and 97 completed the two visits; most had a Hoehn and Yahr Stage of 2 and received rasagiline as adjunct therapy. Treatment with rasagiline improved mean ± SD PDSS scores from 96.2 ± 21.6 at baseline to 105.5 ± 21.93 at 2 months (treatment effect 9.1 ± 18.7 points, p=0.003 [n=97]), denoting an improvement in sleep experience. Analysis by item revealed significant differences from baseline in overall quality of sleep, nocturnal restlessness, nocturnal motor symptoms and sleep refreshment (p Conclusions: In this open-label study, two months treatment with rasagiline improved sleep experience in patients with PD. Supported by: Teva Canada Innovation. Disclosure: Dr. Panisset has received personal compensation for activities with Teva Neuroscience, Novartis, Allergan, and Merz.Dr. Panisset has received research support from Teva Neuroscience, Novartis, and Allergan. Dr. Chouinard has received personal compensation for activities with Teva Neuroscience, Novartis, Shires, and Prestwick. Dr. Chouinard has received personal compensation in an editorial capacity from Novartis. Dr. Chouinard has received research support from Novartis, Teva Neuroscience, Elan Corporation, Schering-Plough Corporation, Merck & Co., Inc., Kyowa, and Amarin.