A Controlled Trial of Rotigotine Monotherapy in Early Parkinson's Disease

BACKGROUND: Oral dopamine agonists are effective for treating early Parkinson's disease (PD). Rotigotine is a dopamine agonist delivered through a silicone-based transdermal patch that is replaced every 24 hours. OBJECTIVES: To assess the efficacy and safety of rotigotine in patients with PD not receiving dopaminergic medications. DESIGN: Randomized, double-blind, placebo-controlled study. Patients Two hundred forty-two patients with early PD. Intervention Treatment with patches containing either 4.5, 9.0, 13.5, or 18.0 mg of rotigotine or placebo for 11 weeks. Main Outcome Measure The change in the sum of the scores of the activities of daily living and motor components of the Unified Parkinson's Disease Rating Scale from baseline to the end of treatment. RESULTS: There was a significant dose-related improvement in the motor and activities of daily living Unified Parkinson's Disease Rating Scale score between baseline and week 11 for the 13.5- and 18.0-mg groups compared with placebo (placebo, 0.3 +/- 7.7; 13.5-mg group, 5.1 +/- 7.0, P =.001; 18.0-mg group, 5.3 +/- 7.0, P<.001). Adverse experiences that occurred more commonly among subjects randomized to active treatment vs placebo included nausea, application site reactions, dizziness, insomnia, somnolence, vomiting, and fatigue. CONCLUSIONS: Rotigotine can be safely administered once daily transdermally and improves parkinsonian signs in patients with early PD.