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From the Clinical Neuroscience Center (P.A.L.), Southfield, and The Departments of Neurology, Psychiatry, and Behavioral Neurosciences, Wayne State University School of Medicine, Detroit, MI; and University of Kansas Medical Center (K.E.L., R.P.), Department of Neurology, Kansas City.
Address correspondence and reprint requests to Dr. Peter A. LeWitt, Clinical Neuroscience Center, 26400 West Twelve Mile Road, Suite 180, Southfield, MI 48034; e-mail: palewitt{at}ameritech.net
Background: In patients experiencing motor fluctuations, a major treatment challenge is the reduction of "off" time, particularly upon awakening. Rotigotine (Neupro) is a novel dopaminergic agonist with 24-hour transdermal delivery.
Methods: A randomized, double-blind, placebo-controlled trial (PREFER Study) was performed to assess efficacy and safety with two targeted transdermal doses of rotigotine in subjects with advanced Parkinson disease with 
2.5 hours of daily "off" time. Subjects were randomized to receive placebo patches (n = 120) or rotigotine up to either 8 mg/24 hours (n = 120) or 12 mg/24 hours (n = 111). The primary efficacy measures compared changes from baseline to the end of week 24 in the number of daily hours "off" and responder rates for subjects achieving 30% reduction in "off" time.
Results: Compared to placebo, there were significant decreases in mean "off" time of 1.8 hours/day for the rotigotine 8 mg/24 hours group and 1.2 hours/day for the 12 mg/24 hours group. For rotigotine 8 and 12 mg/24 hours groups, 30% responder rates were 56.6% and 55.1% compared to the 34.5% placebo response. "On" time without dyskinesia after awakening was more than doubled in both rotigotine treatment groups vs placebo. Drug-related adverse effects included typical dopaminergic side effects, which were generally mild/moderate in intensity. Patch application site reactions including erythema and pruritus were mild to moderate and transient in the majority of instances.
Conclusions: Transdermal rotigotine significantly improved "off" time in subjects with Parkinson disease not optimally controlled with levodopa and was safe and well tolerated, with typical dopaminergic side effects and occasional application site reactions.
*Principal investigators of the SP 650 Study Group are listed in the appendix.
Disclosure: P.A. LeWitt has received research grant support (>$10,000) and has been a consultant advisor to Schwarz Pharma, GlaxoSmithKline, Boehringer-Ingelheim, Teva, Novartis, and other pharmaceutical firms; K.E. Lyons has received research grant support from GlaxoSmithKline and has been a consultant for Teva, GlaxoSmithKline, Novartis, Schwarz Pharma, and Medtronic; R. Pahwa has received research grant support or participated in clinical trials for GlaxoSmithKline, Novartis, Boehringer-Ingelheim, Medtronic, Schwarz Pharma, and Teva, is a consultant for GlaxoSmithKline, Teva, Novartis, Schwarz Pharma, Boehringer-Ingelheim, Medtronic, and Valeant, and is a speaker for GlaxoSmithKline, Novartis, and Medtronic.
Received July 25, 2006. Accepted in final form December 8, 2006.
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Neurology 2007 68: 1243-1244.
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