A Randomized Double-Blind Placebo-Controlled Phase III Trial of Selegiline Monotherapy for Early Parkinson Disease

作者：Mizuno Yoshikuni^*; Hattori Nobutaka; Kondo Tomoyoshi; Nomoto Masahiro; Origasa Hideki; Takahashi Ryosuke; Yamamoto Mitsutoshi; Yanagisawa Nobuo

来源：Clinical Neuropharmacology, 2017, 40(5): 201-207.

DOI：10.1097/WNF.0000000000000239

• Parkinson disease
• treatment
• selegiline
• monotherapy
• UPDRS

Background: In Japan, selegiline has been approved for combination therapy with levodopa for Parkinson disease (PD). We conducted a trial of selegiline monotherapy for early PD.
Methods: In this 12-week controlled phase III trial, a total of 292 subjects were randomized to receive placebo (n = 146) (full analysis set 140) or selegiline (n = 146) (full analysis set 139). The primary outcome measure was the change in the Unified Parkinson Disease Rating Scale part I + II + III total score from baseline to the final visit. Other secondary measures and a safety profile were evaluated.
Results: Selegiline monotherapy reduced the primary outcome measure by -6.26 +/- 7.86 compared with the placebo -3.14 +/- 6.98 (mean +/- SD, P = 0.0005 by analysis of covariance). There was no significant difference in the number of adverse events between the 2 groups (P > 0.05).
Conclusions: Selegiline monotherapy reduced the total Unified Parkinson Disease Rating Scale part I + II + III score and was well tolerated in Japanese patients with early PD.

• 出版日期2017-10