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

Clin Neuropharmacol. 2017 Sep/Oct;40(5):201-207. doi: 10.1097/WNF.0000000000000239.


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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antiparkinson Agents / therapeutic use
  • Double-Blind Method
  • Early Medical Intervention / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Selegiline / adverse effects
  • Selegiline / therapeutic use*
  • Severity of Illness Index


  • Antiparkinson Agents
  • Selegiline