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

• Published in: Parkinsonism & related disorders Vol. 60; pp. 146 - 152
• Main Authors: Hattori, Nobutaka, Takeda, Atsushi, Takeda, Shinichi, Nishimura, Akira, Kitagawa, Tadayuki, Mochizuki, Hideki, Nagai, Masahiro, Takahashi, Ryosuke
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.03.2019
• Subjects: Adult; Aged; Double-Blind Method; Drug-Related Side Effects and Adverse Reactions - etiology; Female; Humans; Indans - administration & dosage; Indans - adverse effects; Indans - pharmacology; Japan; Japanese; Male; MAO-B inhibitor; MDS-UPDRS; 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; Parkinson's disease; Rasagiline; Severity of Illness Index; Japan; MAO-B inhibitor; Parkinson's disease; Japanese; Rasagiline; MDS-UPDRS
• ISSN: 1353-8020; 1873-5126
• DOI: 10.1016/j.parkreldis.2018.08.024

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). 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. 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%). 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. •First phase 3 study of rasagiline monotherapy in Japanese patients with early PD.•Changes in MDS-UPRDS scores were utilized as efficacy endpoints.•Patients received 1 mg/day rasagiline or placebo for 26 weeks.•Rasagiline showed significant improvements in the MDS-UPRDS Part II + III total score.•No new safety concerns were observed.