Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China

Summary

Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations. The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.

Timeline

Start

2012-04

Primary completion

2013-12

Completion

—

Outcome

Met primary endpoint

paper The decrease in the mean UPDRS total score was greater in the rasagiline group than in the placebo group (- 3.18 ± 0.95 vs. - 0.18 ± 0.98, P = 0.025), PMID 30534374 ↗

registry analysis (superiority or other test); Placebo vs Rasagiline; p = 0.0254; Mean Difference (Final Values) -3.00 (75% CI -4.53 to -1.47); ANCOVA NCT01556165 ↗

Publications

• Zhang Z, Wang J, Chen S, Liu C, Zhang B, Peng R, Sun S, Sun X, Zhao G, Qu Q, Li Y, Zhu S, Pan X, Shao M, Wang Y. Efficacy and safety of rasagiline in Chinese patients with early Parkinson's disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study. Transl Neurodegener. 2018 Dec 6;7:32. doi: 10.1186/s40035-018-0137-5. eCollection 2018.

Drugs

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

Indications