Rasagiline monotherapy in early Parkinson's disease: A phase 3, randomized study in Japan

Parkinsonism Relat Disord. 2019 Mar:60:146-152. doi: 10.1016/j.parkreldis.2018.08.024. Epub 2018 Sep 1.

Abstract

Background: Rasagiline is a monoamine oxidase type-B inhibitor in development in Japan for Parkinson's disease (PD). The objective of this Phase 3, randomized, double-blind study was to evaluate the efficacy and safety of rasagiline in Japanese patients with early PD (NCT02337725).

Methods: Patients were 30-79 years old with a diagnosis of PD within 5 years. Following a two-week placebo run-in period, patients were randomized 1:1 to receive rasagiline (1 mg/day) or placebo for up to 26 weeks. The primary endpoint was change from baseline in the MDS-UPDRS Part II + III total score (TS). Secondary endpoints included the MDS-UPDRS Parts II + III, III, II, and I TS and safety.

Results: In total, 118 patients were randomized to rasagiline and 126 to placebo. Patient characteristics at baseline were similar in both groups. The change from baseline in the MDS-UPDRS Part II + III TS was significantly greater in the rasagiline vs. placebo group (rasagiline-placebo: -6.39, 95% CI: -8.530, -4.250; P < 0.0001). The mean changes from baseline in the MDS-UPDRS Part II + III, Part III and Part II TS were lower at treatment visits between weeks 6 and 26 in the rasagiline vs. placebo groups. The overall incidence of treatment-emergent adverse events (TEAEs) was 62.4% and 52.4% in the rasagiline and placebo groups, respectively; most frequent TEAE was nasopharyngitis (15.4% and 15.1%).

Conclusion: Treatment with oral rasagiline 1 mg/day was effective and well-tolerated in Japanese patients with early PD, with a significantly greater improvement in the MDS-UPDRS Part II + III TS vs. placebo, and a similar safety profile.

Keywords: Japanese; MAO-B inhibitor; MDS-UPDRS; Parkinson's disease; Rasagiline.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions / etiology
  • Female
  • Humans
  • Indans / administration & dosage
  • Indans / adverse effects
  • Indans / pharmacology*
  • Japan
  • Male
  • Middle Aged
  • Monoamine Oxidase Inhibitors / administration & dosage
  • Monoamine Oxidase Inhibitors / adverse effects
  • Monoamine Oxidase Inhibitors / pharmacology*
  • Nasopharyngitis / chemically induced
  • Outcome Assessment, Health Care*
  • Parkinson Disease / drug therapy*
  • Severity of Illness Index

Substances

  • Indans
  • Monoamine Oxidase Inhibitors
  • rasagiline

Associated data

  • ClinicalTrials.gov/NCT02337725