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. 2018 Jun 30:7:14.
doi: 10.1186/s40035-018-0119-7. eCollection 2018.

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

Zhenxin Zhang  1 , Ming Shao  2 , Shengdi Chen  3 , Chunfeng Liu  4 , Rong Peng  5 , Yansheng Li  6 , Jian Wang  7 , Suiqiang Zhu  8 , Qiumin Qu  9 , Xiaoying Zhang  10 , Haibo Chen  11 , Xiangru Sun  12 , Yanping Wang  13 , Shenggang Sun  14 , Baorong Zhang  15 , Jimei Li  16 , Xiaoping Pan  17 , Gang Zhao  18
Affiliations

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

Zhenxin Zhang et al. Transl Neurodegener. .

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.

Keywords: Adjunct; China; Motor fluctuations; OFF time; Parkinson’s disease; Quality of life; Rasagiline.

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Conflict of interest statement

Each study site was granted approval by the respective hospital’s ethics committee. Prior to enrolment, investigators provided patients with information about the study, and written, informed consent was obtained from all patients prior to any study-related activities. The study was performed in compliance with the principles of Good Clinical Practice, and was designed and conducted in accordance with the principles of the Declaration of Helsinki.Not applicable.The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow of patients through the study.a3 patients did not receive treatment and were excluded from the APTS. b11 patients did not have valid post-baseline diaries and were excluded from the FAS; 2 further patients (in the placebo group) were excluded from the primary efficacy analysis due to having no baseline diaries, but were in the FAS for all non-diary-related endpoints. APRS = all-patients-randomized set; APTS = all-patients-treated set; FAS = full-analysis set (modified intent-to-treat)
Fig. 2
Fig. 2
Changes from baseline in total daily OFF time. a Primary endpoint: mean change from baseline, averaged over visits at Weeks 4, 8, 12 and 16, in total daily OFF time (full-analysis set, analysis of covariance, observed cases). b Adjusted change from baseline in total daily OFF time (full-analysis set, analysis of covariance, last observation carried forward). SE = standard error
See this image and copyright information in PMC

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