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

ObjectiveWe aimed to ascertain the efficacy and safety of transdermal rotigotine (2 and 3 mg/24 h) in Japanese patients with restless legs syndrome (RLS).MethodsIn our double-blind placebo-controlled study, 284 Japanese patients with idiopathic RLS were randomly assigned to receive rotigotine 2 mg/24 h or 3 mg/24 h, or placebo, for 13 weeks. The primary endpoint was the change in International Restless Legs Syndrome Study Group rating scale (IRLS) total score.ResultsThe placebo-subtracted decreases in IRLS total score for rotigotine 2 mg/24 h and 3 mg/24 h 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 2 mg/24 h, 3 mg/24 h, 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.ConclusionsOur results showed that rotigotine was effective without major safety concerns at doses of up to 3 mg/24 h in Japanese patients with RLS.