Transdermal rotigotine in early stage Parkinson's disease: A randomized, double-blind, placebo-controlled trial

ABSTRACT Background We conducted a randomized, double‐blind, placebo‐controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan. Methods Patients received once‐daily rotigotine 2 to 16 mg/24 hours (mean dose, 12.8 mg/24 hours; n = 82) or placebo (n = 90) for 12 weeks. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) and part III (motor function) scores from baseline to the end of treatment. Results The mean (± standard deviation) changes in UPDRS part II and III scores were −8.4 ± 9.7 in the rotigotine group and −4.1 ± 8.2 in the placebo group and were significantly different (P = 0.002). More patients in the rotigotine group than in the placebo group had a ≥20% score reduction. No serious drug‐related adverse events were reported. Conclusions Rotigotine at doses up to 16 mg/24 hours was well tolerated and improved function in patients with early stage PD. © 2013 International Parkinson and Movement Disorder Society