Rotigotine transdermal system for the management of motor function and sleep disturbances in Parkinson’s disease: Results from a 1-year, open-label extension of the RECOVER study

Abstract

In RECOVER, a multinational, double-blind, placebo-controlled trial, continuous 24-h transdermal delivery of rotigotine resulted in significant improvements in early-morning motor function and nocturnal sleep disturbances in subjects with idiopathic Parkinson’s disease (PD). On completion of RECOVER, subjects were eligible to enter a 1-year, open-label extension in which they received rotigotine (2–16mg/24h) for a 10-month maintenance period. Safety and tolerability were assessed by monitoring adverse events, changes in vital signs, physical and neurological findings, ECGs, and clinical laboratory values. The primary efficacy measure was the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (Motor Examination) with the modified Parkinson’s Disease Sleep Scale (PDSS-2) as a co-primary measure. Of 84 subjects from RECOVER who enrolled, 79% completed 1year of open-label treatment. Rotigotine was well tolerated; the most common adverse events (AEs; open-label phase) were application site reactions (ASRs; 24%); somnolence and hallucinations (13% each); nausea and fall (12% each); and dizziness and dyskinesia (11% each). Most were mild or moderate in intensity and had resolved at the end of the trial. Twelve subjects (14%) discontinued due to AEs, most commonly ASRs (5 subjects) and peripheral edema (2 subjects). At end of maintenance, the mean UPDRS Part III score was improved by 5.8 (±9.4) points relative to open-label baseline and 10.9 (±10.7) points relative to double-blind baseline and the mean PDSS-2 score by 5.8 (±7.8) points relative to double-blind baseline. Hence, the beneficial effects of rotigotine transdermal system on motor function and sleep disturbances were sustained for up to 1year.