A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Participants

Phase 2/3 Completed 404 enrolled Takeda

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (0.5 mg or 1 mg/day) as an add-on to levodopa in Japanese participants with Parkinson's disease with wearing-off phenomenon.

Timeline

Start: 2015-01-27
Primary completion: 2016-09-17
Completion: 2016-09-17

Outcome

Met primary endpoint

registry analysis (unspecified test); Placebo vs TVP-1012 1 mg; p = 0.0006; LS Mean Difference -0.84 (95% CI -1.320 to -0.364); ANCOVA NCT02337738 ↗

registry analysis (unspecified test); Placebo vs TVP-1012 0.5 mg; p = 0.0140; LS Mean Difference -0.60 (95% CI -1.070 to -0.122); ANCOVA NCT02337738 ↗

Publications

Hattori N, Takeda A, Hanya Y, Kitagawa T, Arai M, Furusawa Y, Mochizuki H, Nagai M, Takahashi R. Effects of rasagiline on Parkinson's Disease Questionnaire (PDQ-39) emotional well-being domain in patients with Parkinson's disease: A post-hoc analysis of clinical trials in Japan. PLoS One. 2022 Jan 25;17(1):e0262796. doi: 10.1371/journal.pone.0262796. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rasagiline	Small molecule	0.5 mg	Oral
Subject	Rasagiline	Small molecule	1 mg	Oral