PMID- 24055212 OWN - NLM STAT- MEDLINE DCOM- 20140708 LR - 20221207 IS - 1878-5506 (Electronic) IS - 1389-9457 (Linking) VI - 14 IP - 11 DP - 2013 Nov TI - Efficacy and safety of rotigotine in Japanese patients with restless legs syndrome: a phase 3, multicenter, randomized, placebo-controlled, double-blind, parallel-group study. PG - 1085-91 LID - S1389-9457(13)00280-3 [pii] LID - 10.1016/j.sleep.2013.07.007 [doi] AB - 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. CI - Copyright (c) 2013 Elsevier B.V. All rights reserved. FAU - Inoue, Yuichi AU - Inoue Y AD - Department of Somnology, Tokyo Medical University, 6-1-1 Shinjuku, Shinjuku-ku, Tokyo 160-8402, Japan. Electronic address: inoue@somnology.com. FAU - Shimizu, Tetsuo AU - Shimizu T FAU - Hirata, Koichi AU - Hirata K FAU - Uchimura, Naohisa AU - Uchimura N FAU - Ishigooka, Jun AU - Ishigooka J FAU - Oka, Yasunori AU - Oka Y FAU - Ikeda, Junji AU - Ikeda J FAU - Tomida, Takayuki AU - Tomida T FAU - Hattori, Nobutaka AU - Hattori N CN - Rotigotine Trial Group LA - eng SI - ClinicalTrials.gov/NCT01084551 PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20130821 PL - Netherlands TA - Sleep Med JT - Sleep medicine JID - 100898759 RN - 0 (Dopamine Agonists) RN - 0 (Placebos) RN - 0 (Tetrahydronaphthalenes) RN - 0 (Thiophenes) RN - 87T4T8BO2E (rotigotine) SB - IM MH - Aged MH - Asian People MH - Dopamine Agonists/*administration & dosage/*adverse effects MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Placebos MH - Restless Legs Syndrome/complications/*drug therapy MH - Severity of Illness Index MH - Sleep/drug effects MH - Sleep Initiation and Maintenance Disorders/drug therapy/etiology MH - Tetrahydronaphthalenes/*administration & dosage/*adverse effects MH - Thiophenes/*administration & dosage/*adverse effects OTO - NOTNLM OT - Clinical trial OT - International Restless Legs Study Group rating scale OT - Japan OT - Pittsburgh Sleep Quality Index OT - Restless legs syndrome OT - Rotigotine FIR - Kousaka, Masako IR - Kousaka M FIR - Kanno, Osamu IR - Kanno O FIR - Kanbayashi, Takashi IR - Kanbayashi T FIR - Kaneko, Yasuyuki IR - Kaneko Y FIR - Katayama, Souichi IR - Katayama S FIR - Hatano, Taku IR - Hatano T FIR - Murata, Miho IR - Murata M FIR - Nakajima, Tohru IR - Nakajima T FIR - Endo, Takurou IR - Endo T FIR - Shibui, Kayo IR - Shibui K FIR - Hayashida, Kenichi IR - Hayashida K FIR - Tada, Kouji IR - Tada K FIR - Komagamine, Masazumi IR - Komagamine M FIR - Muraoka, Hideo IR - Muraoka H FIR - Miki, Kazuhira IR - Miki K FIR - Sasaki, Mitsuo IR - Sasaki M FIR - Tanaka, Haruhito IR - Tanaka H FIR - Sasanabe, Ryuujiro IR - Sasanabe R FIR - Kume, Akito IR - Kume A FIR - Koike, Shigefumi IR - Koike S FIR - Yamada, Naoto IR - Yamada N FIR - Tanaka, Toshihiko IR - Tanaka T FIR - Emura, Narutsugu IR - Emura N FIR - Egawa, Isao IR - Egawa I FIR - Kuroda, Kenji IR - Kuroda K FIR - Kodama, Mitsuo IR - Kodama M FIR - Taniguchi, Mitsutaka IR - Taniguchi M FIR - Kyoutani, Kyouko IR - Kyoutani K FIR - Hiwatani, Yasuhiro IR - Hiwatani Y FIR - Nomoto, Masahiro IR - Nomoto M FIR - Kawada, Seiichi IR - Kawada S FIR - Hashidume, Yuuji IR - Hashidume Y FIR - Sasagasako, Naokazu IR - Sasagasako N FIR - Ariyoshi, You IR - Ariyoshi Y FIR - Yamaguchi, Yuji IR - Yamaguchi Y FIR - Tsuda, Tohru IR - Tsuda T FIR - Ikegami, Azusa IR - Ikegami A FIR - Tsuruta, Kazuhito IR - Tsuruta K FIR - Takaoka, Toshio IR - Takaoka T FIR - Touyama, Kazuyo IR - Touyama K EDAT- 2013/09/24 06:00 MHDA- 2014/07/09 06:00 CRDT- 2013/09/24 06:00 PHST- 2012/12/03 00:00 [received] PHST- 2013/07/25 00:00 [revised] PHST- 2013/07/27 00:00 [accepted] PHST- 2013/09/24 06:00 [entrez] PHST- 2013/09/24 06:00 [pubmed] PHST- 2014/07/09 06:00 [medline] AID - S1389-9457(13)00280-3 [pii] AID - 10.1016/j.sleep.2013.07.007 [doi] PST - ppublish SO - Sleep Med. 2013 Nov;14(11):1085-91. doi: 10.1016/j.sleep.2013.07.007. Epub 2013 Aug 21.