Transdermal rotigotine: double-blind, placebo-controlled trial in Parkinson disease.
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.


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


METHODS
Fifty sites in the United States and Canada.


METHODS
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.


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


METHODS
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.


CONCLUSIONS
The rotigotine transdermal system consistently demonstrated statistically significant and clinically relevant efficacy over placebo in patients with early Parkinson disease and was well tolerated.
Jankovic
Joseph
J
Parkinson's Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas 77030, USA. josephj@bcm.tmc.edu
Watts
Ray L
RL
Martin
Wayne
W
Boroojerdi
Babak
B
D000203:Activities of Daily Living; D000279:Administration, Cutaneous; D000368:Aged; D016022:Case-Control Studies; D018492:Dopamine Antagonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy* / Q000453:epidemiology; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*
D018492:Dopamine Antagonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine