Advanced Parkinson disease treated with rotigotine transdermal system: PREFER Study

Area of Science:

• Neurology
• Pharmacology

Background:

• Motor fluctuations, particularly upon awakening, pose a significant challenge in Parkinson disease management.
• Rotigotine, a novel dopaminergic agonist, offers 24-hour transdermal delivery for continuous symptom control.

Purpose of the Study:

• To evaluate the efficacy and safety of transdermal rotigotine in advanced Parkinson disease patients experiencing motor fluctuations.
• To assess the reduction of "off" time and improvement in "on" time without dyskinesia.

Main Methods:

• A randomized, double-blind, placebo-controlled trial (PREFER Study) involving patients with Parkinson disease and at least 2.5 hours of daily "off" time.
• Participants received either placebo, rotigotine 8 mg/24 hours, or rotigotine 12 mg/24 hours for 24 weeks.
• Primary efficacy measures included changes in daily "off" time and responder rates for a >=30% reduction in "off" time.

Main Results:

• Rotigotine groups showed significant reductions in mean "off" time (1.8 hours/day for 8 mg and 1.2 hours/day for 12 mg) compared to placebo.
• Responder rates for >=30% reduction in "off" time were 56.6% (8 mg) and 55.1% (12 mg) for rotigotine versus 34.5% for placebo.
• "On" time without dyskinesia after awakening more than doubled in rotigotine groups compared to placebo.

Conclusions:

• Transdermal rotigotine effectively improved "off" time in Parkinson disease patients not optimally managed with levodopa.
• The treatment demonstrated a favorable safety profile, with generally mild to moderate dopaminergic side effects and transient application site reactions.