Evaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 8
- 主要终点
- Efficacy of rasagiline vs placebo as assessed by the change from baseline to week 14 in mean total daily OFF time measured by patients' home diaries in levodopa-treated PD patients with motor fluctuations.
研究概览
简要总结
The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
详细描述
Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of rasagiline, a MAO-B inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations.
The objective of this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in PD patients with motor fluctuations on levodopa therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic PD
- •Patients receiving at least 300 mg daily doses of levodopa and not less than 8 daily doses of levodopa with the stable dose
- •Patient with a Modified Hoehn and Yahr stage between 2 to 4 in the OFF state
- •Patient with motor fluctuations averaging at least 2 hour daily in the OFF state
- •Patients who have demonstrated the ability to keep accurate 24-hour diaries
排除标准
- •Patients with Parkinsonian syndrome induced by medicine, metabolic disease, Encephalitis and central nervous system degenerative diseases or Disease of basal ganglia
- •Patients with severe cognitive impairment judged by a Mini Mental State Examination
- •Patients with a clinically significant psychiatric illness
- •Patients with Hamilton Depression Rating Scale (HAMD): total score ≤10
- •Patients with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation
- •Patients with a clinically significant or unstable vascular disease
- •Patients with severe disabling dyskinesias Other inclusion and exclusion criteria may apply
研究组 & 干预措施
Rasagiline
Rasagiline 0.5 mg by mouth every day for 2 weeks, then 1 mg by mouth every day for 12 weeks, then switch to 0.5mg by mouth every day for remainder of the study (approximately 16 weeks total)
干预措施: Rasagiline (Drug)
Placebo
placebo 0.5 mg by mouth every day for two weeks, then 1 mg by mouth every day for 12 weeks, then switch to 0.5mg by mouth every day for remainder of the study (approximately 16 weeks total)
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of rasagiline vs placebo as assessed by the change from baseline to week 14 in mean total daily OFF time measured by patients' home diaries in levodopa-treated PD patients with motor fluctuations.
时间窗: 0, 14 weeks
次要结局
- Change from baseline to week 6/10/16 in mean total daily OFF time measured by patients' home diaries.(0, 6, 10, 16 weeks)
- Adverse Events: the occurrence of melanoma.(0, 2, 6, 10, 14, 16 weeks)
- Grade of UPDRS I(0, 6, 14, 16 weeks)
- Change from baseline to week 6/14/16 in mean total daily ON time measured by patients' home diaries.(0, 6, 14, 16 weeks)
- Change from baseline to week 6/14/16 on Unified Parkinson's Disease Rating Scale (UPDRS) Ⅱ- Ⅵ Activities of Daily Living.(0, 6, 14, 16 weeks)
- Change from baseline to week 6/10/14/16 in mean total daily ON time measured by patients' home diaries.(0, 6, 10, 14, 16 weeks)
- Blood routine、 urine routine、 ALT、 AST、 TBiL、 γ-GTP、 ALP、 BUN、 Cr、 ECG.(0, 6, 16 weeks)
- Analysis of the changing rate of the UPDRSⅡ -Ⅵ after treatment of week 6/14/16.(0, 6, 14, 16 weeks)
- The rate of patients whose Levodopa dose is adjusted after 6/14/16 weeks of treatment.(0, 2, 6, 14, 16 weeks)
- BP、 temperature、 breath and heart rate after 5 minutes of stasis.(-2, 0, 2, 6, 10, 14, 16 weeks)
- Physical examination.(-2, 16 weeks)