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Translational Neurodegeneration
Published in: Translational Neurodegeneration 1/2018

Open Access 01-12-2018 | Research

Adjunct rasagiline to treat Parkinson’s disease with motor fluctuations: a randomized, double-blind study in China

Authors: Zhenxin Zhang, Ming Shao, Shengdi Chen, Chunfeng Liu, Rong Peng, Yansheng Li, Jian Wang, Suiqiang Zhu, Qiumin Qu, Xiaoying Zhang, Haibo Chen, Xiangru Sun, Yanping Wang, Shenggang Sun, Baorong Zhang, Jimei Li, Xiaoping Pan, Gang Zhao

Published in: Translational Neurodegeneration | Issue 1/2018

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Abstract

Background

The use of adjunct rasagiline in levodopa-treated patients with Parkinson’s disease and motor fluctuations is supported by findings from large-scale clinical studies. This study is to investigate the efficacy and safety of adjunct rasagiline in Chinese patients with Parkinson’s disease, as a product registration study.

Methods

This 16-week, randomized, double-blind, parallel-group, multicenter, placebo-controlled study of rasagiline 1 mg/day included levodopa-treated patients with Parkinson’s disease and motor fluctuations. The primary efficacy endpoint was mean change from baseline in total daily OFF time over 16 weeks. Secondary endpoints were Clinical Global Impressions – Improvement (CGI-I), and change in Unified Parkinson’s Disease Rating Scale (UPDRS) Activities of daily living (ADL) and Motor scores. Patient well-being (EQ-5D), and the frequency of adverse events were also assessed.

Results

In total, 324 levodopa-treated patients were randomized to rasagiline 1 mg/day (n = 165) or placebo (n = 159). Over 16 weeks, rasagiline statistically significantly reduced the mean [95% confidence interval] total daily OFF time versus placebo (− 0.5 h [− 0.92, − 0.07]; p = 0.023). There were also statistically significant improvements versus placebo in CGI-I (− 0.4 points [− 0.61, − 0.22]; p < 0.001), UPDRS-ADL OFF (− 1.0 points [− 1.75, − 0.27]; p = 0.008), and UPDRS-Motor ON (− 1.6 points [− 3.05, − 0.14]; p = 0.032) scores, as well as the EQ-5D utility index (p < 0.05). Rasagiline was safe and well tolerated.

Conclusions

In levodopa-treated Chinese patients with Parkinson’s disease and motor fluctuations, adjunct rasagiline 1 mg/day statistically significantly reduced OFF time, and improved daily function and overall well-being, versus placebo. Consistent with findings in other countries, adjunct rasagiline was proven efficacious and well tolerated in Chinese patients.

Trial registration number

NCT01479530. Registered 22 November 2011.
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Metadata
Title
Adjunct rasagiline to treat Parkinson’s disease with motor fluctuations: a randomized, double-blind study in China
Authors
Zhenxin Zhang
Ming Shao
Shengdi Chen
Chunfeng Liu
Rong Peng
Yansheng Li
Jian Wang
Suiqiang Zhu
Qiumin Qu
Xiaoying Zhang
Haibo Chen
Xiangru Sun
Yanping Wang
Shenggang Sun
Baorong Zhang
Jimei Li
Xiaoping Pan
Gang Zhao
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Translational Neurodegeneration / Issue 1/2018
Electronic ISSN: 2047-9158
DOI
https://doi.org/10.1186/s40035-018-0119-7

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