2.242 BRAIN AND PERIPHERAL LEVODOPA PHARMACOKINETICS IN THE CYNOMOLGUS MONKEY FOLLOWING ADMINISTRATION OF OPICAPONE, A NOVEL CATECHOL-O-METHYLTRANSFERASE INHIBITOR

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 1.0mg once daily per Canadian label). Subjects were assessed at baseline and after 2 months of treatment using the Parkinson’s 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 < 0.05). Although there was a small improvement in ESS scores, it was not statistically significant. Conclusions: In this open-label study, two months treatment with rasagiline improved sleep experience in patients with PD.