A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients

Summary

The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day) administered to Japanese patients with early Parkinson's disease.

Timeline

Start

2015-02-07

Primary completion

2016-09-15

Completion

2016-09-15

Outcome

Met primary endpoint

paper 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). PMID 30205936 ↗

Publications

• Hattori N, Takeda A, Takeda S, Nishimura A, Kitagawa T, Mochizuki H, Nagai M, Takahashi R. 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.

Drugs

Indications