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

Abstract

BackgroundThe 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.MethodsThis 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.ResultsIn 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.ConclusionsIn 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 numberNCT01479530. Registered 22 November 2011.

Freezing of gait in Parkinson’s disease: pathophysiology, risk factors and treatments

“…Hypokinesia of limb and trunk movements were not improved in this study indicating the beneficial effect exerted by selegiline add-on therapy was not by dopaminergic pathway [70]. Rasagiline, as an effective monotherapy in early PD and add-on therapy in PD patients with motor fluctuations [71,[104][105][106], has also been studied on FOG. In the LARGO study [71], a prospective, double-blind, randomized, placebo-controlled study enrolled 687 PD patients, in which 278 patients had FOG.…”

Efficacy and safety of rasagiline in Chinese patients with early Parkinson’s disease: a randomized, double-blind, parallel, placebo-controlled, fixed-dose study

“…No studies have specifically examined and manifested the efficacy, tolerability and safety of rasagiline monotherapy in Chinese patients with PD, although the efficacy of rasagiline administration as adjunct therapy to levodopa in this population has been confirmed [ 14 , 15 ]. Therefore, this randomized, double-blind, parallel, placebo-controlled, fixed-dose study aimed to evaluate the efficacy and safety of rasagiline in Chinese patients with early PD not treated with levodopa.…”

Clinical Experience with Generic Rasagiline (Ralago&lt;sup&gt;&amp;reg;&lt;/sup&gt;) in Patients with Parkinson’s Disease: An Open-Label, Multicenter, Observational Study

“…Adverse events related to the drug completely disappeared after withdrawal. Comparing the results of safety analysis of this study to those of other clinical trials investigating other rasagiline-containing products[7] [10][31] concerning frequency and severity of adverse events, the safety profile of Ralago ® seems to be somewhat better. As PD usually occurs in the older population which is more prone to be affected by side effects of pharmacotherapy because of polimorbidity and drug interactions, antiparkinsonian medications with higher safety should be preferred in these patients.…”

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