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

Zhang, Zhenxin; Wang, Jian; Chen, Shengdi; Liu, Chun‐Feng; Zhang, Baorong; Peng, Rong; Sun, Shan; Sun, Xiang; Zhao, Gang; Qu, Qing; Li, Yansheng; Zhu, Suiqiang; Pan, Xiaoping; Shao, Ming; Wang, Yanping

doi:10.1186/s40035-018-0137-5

Cited by 10 publications

(15 citation statements)

References 28 publications

(41 reference statements)

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“…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.…”

Section: Monoamine Oxidase B Inhibitors (Mao-b Inhibitor)mentioning

confidence: 64%

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

Gao

Tan

et al. 2020

Transl Neurodegener

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Background: Freezing of gait (FOG) is a common, disabling symptom of Parkinson's disease (PD), but the mechanisms and treatments of FOG remain great challenges for clinicians and researchers. The main focus of this review is to summarize the possible mechanisms underlying FOG, the risk factors for screening and predicting the onset of FOG, and the clinical trials involving various therapeutic strategies. In addition, the limitations and recommendations for future research design are also discussed. Main body: In the mechanism section, we briefly introduced the physiological process of gait control and hypotheses about the mechanism of FOG. In the risk factor section, gait disorders, PIGD phenotype, lower striatal DAT uptake were found to be independent risk factors of FOG with consistent evidence. In the treatment section, we summarized the clinical trials of pharmacological and non-pharmacological treatments. Despite the limited effectiveness of current medications for FOG, especially levodopa resistant FOG, there were some drugs that showed promise such as istradefylline and rasagiline. Non-pharmacological treatments encompass invasive brain and spinal cord stimulation, noninvasive repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) and vagus nerve stimulation (VNS), and physiotherapeutic approaches including cues and other training strategies. Several novel therapeutic strategies seem to be effective, such as rTMS over supplementary motor area (SMA), dual-site DBS, spinal cord stimulation (SCS) and VNS. Of physiotherapy, wearable cueing devices seem to be generally effective and promising.Conclusion: FOG model hypotheses are helpful for better understanding and characterizing FOG and they provide clues for further research exploration. Several risk factors of FOG have been identified, but need combinatorial optimization for predicting FOG more precisely. Although firm conclusions cannot be drawn on therapeutic efficacy, the literature suggested that some therapeutic strategies showed promise.

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Section: Monoamine Oxidase B Inhibitors (Mao-b Inhibitor)mentioning

confidence: 64%

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

Gao

Tan

et al. 2020

Transl Neurodegener

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128

100

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“…The CHORUS study [58] Disease progression, motor complications, dopaminergic medications, severe autonomic dysfunction, presence of hallucination were reported to be associated with sleep disorders for PD patients [84,85].…”

Section: Effects Of Mao-b Inhibitors On Mitochondria and Cell Apoptosismentioning

confidence: 99%

“…The CHORUS study [ 58 ] published in 2018 evaluated the efficacy of rasagiline in Chinese patients with early PD. A total of 127 patients with early treatment-naive PD were included in this randomized controlled study.…”

Section: Pd Symptoms Treated By Mao-b Inhibitorsmentioning

confidence: 99%

Monoamine Oxidase-B Inhibitors for the Treatment of Parkinson’s Disease: Past, Present, and Future

Tan

Jenner

Chen

2022

JPD

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Monoamine oxidase-B (MAO-B) inhibitors are commonly used for the symptomatic treatment of Parkinson’s disease (PD). MAO-B inhibitor monotherapy has been shown to be effective and safe for the treatment of early-stage PD, while MAO-B inhibitors as adjuvant drugs have been widely applied for the treatment of the advanced stages of the illness. MAO-B inhibitors can effectively improve patients’ motor and non-motor symptoms, reduce “OFF” time, and may potentially prevent/delay disease progression. In this review, we discuss the effects of MAO-B inhibitors on motor and non-motor symptoms in PD patients, their mechanism of action, and the future development of MAO-B inhibitor therapy.

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“…According to recent surveys conducted with healthy individuals and PD patients in China and Japan, rasagiline can safely and effectively treat PD symptoms by blocking the decomposition of the neurotransmitter dopamine, with good drug tolerance and long-lasting effects ( Chen et al, 2016 ; Elgart et al, 2019 ; Hattori et al, 2018 ; Zhang et al,2018 ). In general, rasagiline is a novel, safe and effective drug for the management of PD.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics and Bioequivalence of Rasagiline Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: An Open, Randomized, Single-Dose, Double-Cycle, Two-Sequence, Crossover Trial

Lü

Bai

et al. 2020

Front. Pharmacol.

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Objective: This study evaluated the pharmacokinetics, safety, and bioequivalence (BE) of two formulations of rasagiline tablets in healthy Chinese subjects under fasting and fed conditions.Methods: An open, randomized, single-dose, double-cycle, two-sequence, self-crossover pharmacokinetic study in healthy Chinese subjects under fasting and high-fat postprandial conditions was performed. A total of 108 healthy subjects (36 in the fasting group and 72 in the postprandial group) were recruited. In each cycle of the study under both conditions, subjects received a single oral dose of 1 mg of a test or reference preparation of rasagiline tablets (1 mg each). A washout period of 3 days was observed. Blood samples were obtained up to 10 h post-intake. Primary endpoints were the BE of major pharmacokinetic parameters (AUC0–t and AUC0–∞) and the maximum observed serum concentration (Cmax). Secondary endpoints were safety parameters.Results: The 90% confidence interval (CI) of the geometric mean ratio (GMR) of the test drug vs. the reference drug for rasagiline was 94.16–105.35% for the AUC0–t under fasting conditions and 99.88–107.07% under postprandial conditions. The 90% CIs for the AUC0–∞ were 93.55–105.01% and 99.59–107.05% under fasting and postprandial conditions, respectively. The 90% CIs for the Cmax were 88.26–108.46% and 89.54–118.23% under fasting and postprandial conditions, respectively. The 90% CIs for the test/reference AUC ratio and Cmax ratio were within the acceptable range (0.80–1.25) for BE. In this BE study, there were no serious adverse events (AEs).Conclusion: BE between the test and the reference products was established in both fasting and postprandial conditions. The two formulations of rasagiline showed good tolerability and a similar safety profile.Clinical Trial Registration:chinaDrugtrials.org.cn, identifier CTR20181466.

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

Cited by 10 publications

References 28 publications

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

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

Monoamine Oxidase-B Inhibitors for the Treatment of Parkinson’s Disease: Past, Present, and Future

Pharmacokinetics and Bioequivalence of Rasagiline Tablets in Chinese Healthy Subjects Under Fasting and Fed Conditions: An Open, Randomized, Single-Dose, Double-Cycle, Two-Sequence, Crossover Trial

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