By Jill Stein
BOSTON, MA -- May 3, 2007 -- Transdermal rotigotine at doses of 8 and 12 mg/day reduces "off" time in patients with advanced Parkinson's disease who are not optimally controlled with levodopa, researchers reported here at the American Academy of Neurology (AAN) 59th Annual Meeting.
Rotigotine is a nonergolinic dopamine receptor agonist that is formulated as a patch for once-daily use.
"Patients often experience immobility and other types of discomfort in the morning when they wake up, before their first oral dose of medication takes effect," said Peter A. LeWitt, MD, professor of neurology, Wayne State University, Milwaukee, Wisconsin.
Dr. LeWitt discussed the phase 3 results on behalf of the SP Study Group in a presentation on May 3rd. "We found that patients who were treated with rotigotine were significantly more likely to be "on" when they awaken, compared to placebo-treated patients."
The results are from a joint US-Canadian trial known as Prospective Randomized Evaluation of a new Formulation: Efficacy of Rotigotine (PREFER). In this trial, 351 patients with advanced idiopathic Parkinson's disease were randomized to placebo or 2 target doses of rotigotine (up to either 8 mg/24h or 12mg/24h) for up to 7 months.
The trial included a 5-week titration phase followed by a 24-week maintenance phase. Rotigotine was added to stable levodopa treatment.
Primary efficacy measures compared changes from baseline to the end of week 24 in the number of daily hours in the "off" state, and responder rates for subjects achieving 30% or greater reduction in "off" time.
Compared with baseline, mean daily decreases in "off" time were 2.7 hours in patients who were treated with the 8-mg/24-hour dose and 2.1 hours with the 12-mg/24-hour dose. In the placebo group, duration of "off" time decreased by 0.9 hours (P <.001 and P <.003, respectively).
Importantly, these improvements were sustained throughout the 24-week maintenance period.
The study also found that the increase in "on time without troublesome dyskinesia" was greater for both rotigotine groups compared with placebo.
Rotigotine was safe and well tolerated. The most common adverse events in the rotigotine groups were application site reactions, somnolence, nausea and vomiting, and dizziness.
The study was sponsored by Schwarz Pharma.
[Presentation title: Prospective Randomized Evaluation of a New Formulation: Efficacy of Rotigotine (PREFER). Abstract P06.022]
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