title: Transdermal rotigotine in advanced Parkinson's disease: a randomized, double-blind, placebo-controlled trial.
abstract: Rotigotine, a non-ergot dopamine receptor agonist, offers potential for continuous dopaminergic stimulation that could avoid the fluctuations observed with traditional treatments. We conducted a randomized, double-blind, placebo-controlled trial in Japanese patients with advanced Parkinson's disease (PD) to investigate the efficacy and safety of rotigotine. Inclusion criteria included the presence of motor complications, such as wearing off, on-off, delayed-on/no-on, any circumstances that could interfere with levodopa dose escalation because of side effects, or declining levodopa efficacy. The enrolled patients received once-daily applications of rotigotine transdermal patches or matched placebo patches. A total of 174 patients were randomly assigned to rotigotine (87 patients) or placebo (87 patients). The full analysis set included 172 patients (86 for the rotigotine group and 86 for the placebo group). The maximum maintenance dose of rotigotine was set at 16 mg/24 h. The changes in unified PD rating scale Part III scores from baseline to the end of the trial were -10.1 ± 9.0 (mean ± standard deviation) in the rotigotine group and -4.4 ± 7.4 in the placebo group (p < 0.001). There was a significantly greater reduction in the off-time (p = 0.014) in the rotigotine group. Rotigotine was well tolerated, with serious adverse events being reported in only three patients in each group. Rotigotine at doses of up to 16 mg/24 h is efficacious and safe in Japanese patients with advanced PD.
authors.affiliation: Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine, Shitsukawa, Toon, Ehime, 791-0295, Japan, nomoto@m.ehime-u.ac.jp.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Nomoto
authors.forename: Yoshikuni
authors.initials: Y
authors.lastname: Mizuno
authors.forename: Tomoyoshi
authors.initials: T
authors.lastname: Kondo
authors.forename: Kazuko
authors.initials: K
authors.lastname: Hasegawa
authors.forename: Miho
authors.initials: M
authors.lastname: Murata
authors.forename: Masahiro
authors.initials: M
authors.lastname: Takeuchi
authors.forename: Junji
authors.initials: J
authors.lastname: Ikeda
authors.forename: Takayuki
authors.initials: T
authors.lastname: Tomida
authors.forename: Nobutaka
authors.initials: N
authors.lastname: Hattori
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; C047508:rotigotine