Efficacy and safety of rotigotine in Japanese patients with restless legs
syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind,
parallel-group study.
Author(s): Inoue Y(1), Shimizu T, Hirata K, Uchimura N, Ishigooka J, Oka Y, Ikeda J, Tomida
T, Hattori N; Rotigotine Trial Group.
Collaborators: Kousaka M, Kanno O, Kanbayashi T, Kaneko Y, Katayama S, Hatano T,
Murata M, Nakajima T, Endo T, Shibui K, Hayashida K, Tada K, Komagamine M,
Muraoka H, Miki K, Sasaki M, Tanaka H, Sasanabe R, Kume A, Koike S, Yamada N,
Tanaka T, Emura N, Egawa I, Kuroda K, Kodama M, Taniguchi M, Kyoutani K, Hiwatani
Y, Nomoto M, Kawada S, Hashidume Y, Sasagasako N, Ariyoshi Y, Yamaguchi Y, Tsuda
T, Ikegami A, Tsuruta K, Takaoka T, Touyama K.
Affiliation(s): Author information:
(1)Department of Somnology, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku,
Tokyo 160-8402, Japan. Electronic address: inoue@somnology.com.
Publication date & source: 2013, Sleep Med. , 14(11):1085-91
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.
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