Rotigotine transdermal system for control of early morning motor impairment and sleep disturbances in patients with Parkinson’s disease
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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.
KeywordsDopamine agonist Early morning akinesia Parkinson’s disease Rotigotine transdermal patch Sleep disorders
The authors would like to thank all SP826 investigators for their contributions (study conception and design, data collection, and providing and caring for study patients). The authors also thank Dr. E. Grosselindemann and Dr. B. Brett (Brett Medical Writing) for providing medical writing services and editorial assistance, Dr. H. C. Carney (Evidence Scientific Solutions) for editorial assistance, and Ms. G.-G. Li (Global Publications Manager, Movement and Sleep Disorders, UCB Pharma SA) for publication coordination. The study was sponsored by Schwarz Biosciences GmbH, a member of the UCB Group of Companies, delegated by Schwarz Pharma Ltd, Ireland. The sponsor was involved in study design, data analysis and interpretation, report writing, and the decision to submit the paper for publication. The sponsor also undertook all costs associated with the development and the publishing of the present manuscript.
Conflicts of interest
AF and BB are employees of the study sponsor. NG received honoraria for consultancy from the sponsor as part of the International Advisory Board of UCB in regards to Parkinson’s disease. He received no compensation for any work in relation to this paper or this study. WP received honoraria for consultancy and lecture fees from the study sponsor.
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