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

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.