Rotigotine transdermal system for control of early morning motor impairment and sleep disturbances in patients with Parkinson's disease.

This open-label study (NCT00243945) investigated the efficacy of rotigotine transdermal system in 54 Parkinson's disease (PD) patients with unsatisfactory control of early morning motor impairment and sleep disturbances. Rotigotine dose was up titrated for 8 weeks and maintained for 4 weeks. Mean rotigotine dose at end of maintenance was 11.83 mg/24 h (SD 3.86). Patients had two overnight hospital stays at baseline and end of treatment during which early morning motor performance was assessed, prior to first morning dose of regular oral antiparkinsonian medication. Rotigotine improved mean Unified Parkinson's Disease Rating Scale (UPDRS) part III score by -9.3 points, mean Timed Up and Go test duration by -1.4 s and mean morning finger tapping by 26.5 taps/min; 46% of patients were considered responders (≥30% improvement of UPDRS III). Mean Nocturnal Akinesia, Dystonia and Cramps Sum Score was reduced by 61%; mean number of nocturias decreased by 32%. Rotigotine also improved sleep quality. These results suggest a role for rotigotine in treatment of nocturnal and early morning motor disabilities in PD patients.