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.

Appendix: Members of the SPM 962 Rotigotine Trial Group

The authors wish to thank the following additional members of the SPM 962 Rotigotine Trial Group, who participated in this trial as investigators: Takashi Kimura, Hidenao Sasaki, Mikio Shoji, Takashi Abe, Atsushi Takeda, Itaru Toyoshima, Kazuo Yoshizawa, Toshiaki Kamitani, Kimihito Arai, Shigeki Tanaka, Sadako Kuno, Fusako Yokochi, Hiroshi Kurisaki, Noriko Kawashima, Shinji Ohara, Kouichi Mizoguchi, Toshihiko Ohashi, Tetsushi Atsumi, Akira Inukai, Tatsuya Hattori, Hideyuki Sawada, Harutoshi Fujimura, Nobuyoshi Yoshikawa, Sonoko Nozaki, Mitsutoshi Yamamoto, Hiroaki Miyaoka, Masahiro Nagai, Noriko Nishikawa, Tatsuo Yamada, Naokazu Sasagasako, Takayuki Kondo, Shigehiro Imamura, Yoshito Sonoda, Satoshi Takahashi, and Hitoshi Yamada.