Transdermal rotigotine in advanced Parkinson's disease: a randomized,
double-blind, placebo-controlled trial.
Author(s): Nomoto M(1), Mizuno Y, Kondo T, Hasegawa K, Murata M, Takeuchi M, Ikeda J, Tomida
T, Hattori N.
Affiliation(s): Author information:
(1)Department of Neurology and Clinical Pharmacology, Ehime University Graduate
School of Medicine, Shitsukawa, Toon, Ehime, 791-0295, Japan,
nomoto@m.ehime-u.ac.jp.
Publication date & source: 2014, J Neurol. , 261(10):1887-93
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.
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