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


CONCLUSIONS
Our results showed that rotigotine was effective without major safety concerns at doses of up to 3 mg/24 h in Japanese patients with RLS.
Department of Somnology, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan. Electronic address: inoue@somnology.com.
Yuichi
Y
Inoue
Tetsuo
T
Shimizu
Koichi
K
Hirata
Naohisa
N
Uchimura
Jun
J
Ishigooka
Yasunori
Y
Oka
Junji
J
Ikeda
Takayuki
T
Tomida
Nobutaka
N
Hattori
D000368:Aged; D044466:Asian People; D018491:Dopamine Agonists / Q000008:administration & dosage* / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012148:Restless Legs Syndrome / Q000150:complications / Q000188:drug therapy*; D012720:Severity of Illness Index; D012890:Sleep / Q000187:drug effects; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy / Q000209:etiology; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage* / Q000009:adverse effects*; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects*
D018491:Dopamine Agonists; D010919:Placebos; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine
Clinical trial; International Restless Legs Study Group rating scale; Japan; Pittsburgh Sleep Quality Index; Restless legs syndrome; Rotigotine