Efficacy and safety of rotigotine in Japanese patients with restless legs syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group study.

Abstract: Objective: We aimed to ascertain the efficacy and safety of transdermal rotigotine (2 and 3mg/24h) in Japanese patients with restless legs syndrome (RLS). Methods: In our double-blind placebo-controlled study, 284 Japanese patients with idiopathic RLS were randomly assigned to receive rotigotine 2mg/24h or 3mg/24h, or placebo, for 13weeks. The primary endpoint was the change in International Restless Legs Syndrome Study Group rating scale (IRLS) total score. Results: The placebo-subtracted decreases in IRLS total score for rotigotine 2mg/24h and 3mg/24h were −2.8±1.3 and −3.1±1.3, respectively, which were significant (P <0.05). The interaction between baseline Pittsburgh Sleep Quality Index (PSQI) and treatment group for the change in IRLS total score was significant, indicating greater improvements in IRLS total score in patients with severe insomnia. Overall, 80.0%, 86.2%, and 51.6% of patients in the rotigotine 2mg/24h, 3mg/24h, and placebo groups, respectively, experienced adverse events (AEs) including application site reactions in 42.1%, 50.0%, and 7.4% of patients, respectively. None of the AEs were severe. Conclusions: Our results showed that rotigotine was effective without major safety concerns at doses of up to 3mg/24h in Japanese patients with RLS. [Copyright &y& Elsevier]