Rotigotine As Levodopa Adjunct Is Effective In Advanced Parkinson's Disease

Main Category: Parkinson's Disease News
Article Date: 03 May 2007 - 14:00 PDT
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Transdermal rotigotine (Neupro) up to doses of 8 and 12 mg/day as adjunctive therapy to levodopa significantly decreases "off time" in patients with advanced Parkinson's disease, according to phase III data presented at the 59th Annual Meeting of the American Academy of Neurology (AAN).

Peter A. LeWitt, MD, professor of neurology at Wayne State University in Milwaukee, Wisconsin, reported results in 351 patients with advanced idiopathic Parkinson's disease who had been randomized to placebo or two target doses of rotigotine (up to either 8 mg/24h or 12mg/24h) for up to seven months. Rotigotine is a non-ergolinic dopamine receptor agonist available as a patch for once-daily use.

The trial, known as Prospective Randomized Evaluation of a new Formulation: Efficacy of Rotigotine (PREFER), included a five-week titration phase followed by a 24-week maintenance phase.

The primary efficacy variable was change from baseline in absolute off time.

Compared to baseline, mean daily decreases in off time were 2.7 hours with the 8mg/24h dose and 2.1 hours with the 12mg/24h dose compared to a 0.9 hour decrease with placebo (P<0.001 and 0.003, respectively).

Patients who had longer off times at enrollment tended to benefit most. The study also found that "on" time without dysykinesia after awakening was more than doubled in the two rotigotine groups compared with placebo.

The most common adverse events in the rotigotine groups were application site reactions, somnolence, nausea and vomiting, and dizziness.

While many patients with advanced Parkinson's disease have a surge in symptoms between dosages of their medications, the 24-hour duration of transdermal rotigotine offers the potential for extended anti-parkinsonian control lasting through the night into the morning hours after awakening, Dr. LeWitt said.

Rotigotine is a non-ergolinic dopamine receptor agonist formulated as a path for once-daily usage. The study was sponsored by Schwarz Pharma.