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Double-blind, Placebo-Controlled Trial in Parkinson Disease

Joseph Jankovic, MD; Ray L. Watts, MD; Wayne Martin, MD; Babak Boroojerdi, MD; for the SP 512 Rotigotine Transdermal System Clinical Study Group

Arch Neurol. 2007;64(5):676-682.

Objective  To assess the response to the rotigotine transdermal system (Neupro; Schwarz Pharma Ltd, Monheim, Germany), a nonergolinic dopamine agonist, in patients with early Parkinson disease.

Design  Randomized, double-blind, multicenter, placebo-controlled study.

Setting  Fifty sites in the United States and Canada.

Patients  Two hundred seventy-seven patients with early Parkinson disease. Eligibility was assessed by means of routine clinical and neurological examinations. Patients were randomized 2:1 to receive either rotigotine therapy or placebo.

Intervention  Treatment with the rotigotine transdermal system, 2, 4, or 6 mg during 24 hours, for 24 weeks.

Main Outcome Measure  Percentage of subjects achieving a 20% response or greater (reduction) as assessed with the Unified Parkinson Disease Rating Scale subtotal (parts II [activities of daily living] and III [motor function]) from baseline to the end of the maintenance phase.

Results  Significant differences were observed between the rotigotine-treated and placebo groups for the 20% responder rate (48% for the rotigotine group and 19% for the placebo group; P<.001), least squares mean change in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (–941 for rotigotine vs –157 for placebo; P<.001), and percentage changes in Unified Parkinson Disease Rating Scale subtotal (parts II and III) score (–15.1% for rotigotine vs 7.3% for placebo; P<.001). Rotigotine treatment significantly increased the patients' Clinical Global Impression Scale scores (57% for rotigotine vs 30% for placebo; P<.001) and had a positive effect on their quality of life. The most common adverse events were application site reactions, nausea, and somnolence. Twenty-five (14%) of 181 patients in the rotigotine group withdrew from the study because of adverse effects.

Conclusion  The rotigotine transdermal system consistently demonstrated statistically significant and clinically relevant efficacy over placebo in patients with early Parkinson disease and was well tolerated.

Author Affiliations: Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Tex (Dr Jankovic); Department of Neurology, University of Alabama at Birmingham (Dr Watts); Division of Neurology, University of Alberta, Edmonton (Dr Martin); and Schwarz BioSciences, Research Triangle Park, NC (Dr Boroojerdi).

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RELATED LETTERS

Notice of Redundant Publication: "Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease" (Arch Neurol. 2007;64[5]:676-682)
Roger Rosenberg
Arch Neurol. 2007;64(12):1800-1801.
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Notice of Redundant Publication: "Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease" (Arch Neurol. 2007;64[5]:676-682)—Reply
Joseph Jankovic, Ray L. Watts, Wayne Martin, and Babak Boroojerdi
Arch Neurol. 2007;64(12):1801.
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ABSTRACT  

Notice of Redundant Publication: "Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease" (Arch Neurol. 2007;64[5]:676-682)
Rosenberg
Arch Neurol 2007;64:1800-1801.
FULL TEXT  

Notice of Redundant Publication: "Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease" (Arch Neurol. 2007;64[5]:676-682) Reply
Jankovic et al.
Arch Neurol 2007;64:1801-1801.
FULL TEXT