Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 15
- 主要终点
- Change From Baseline to Week 26 in UPDRS Total Score
研究概览
简要总结
Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in levodopa-treated PD patients with motor fluctuations.
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with idiopathic PD.
- •Patients with a Modified Hoehn and Yahr stage <3.
排除标准
- •Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
- •Patients with a clinically significant or unstable vascular disease.
- •Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
- •Patients with a Mini Mental State Examination (MMSE) score ≤
- •Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
rasagiline
干预措施: rasagiline (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 26 in UPDRS Total Score
时间窗: Baseline to Week 26
The Unified Parkinson's Disease Rating Scale (UPDRS) is a 42-item rating scale designed to assess Parkinson's disease-related disability and impairment. The scale comprises four parts: Part I evaluates mentation, behaviour, and mood symptoms; Part II evaluates activities of daily living (ADL); Part III evaluates motor function; and Part IV evaluates complications of dopaminergic therapy. The total score is the sum of the subscale scores for Parts I to III and ranges from 0 (no disability) to 176 (total dependence).
次要结局
- Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part III)(Baseline to Week 26)
- Time to Onset of Levodopa Therapy(Baseline to Week 26)
- Levodopa Administration Within 26 Weeks(Baseline to Week 26)
- Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part I)(Baseline to Week 26)
- Change From Baseline to Week 26 in Subscale Scores of the UPDRS (Part II)(Baseline to Week 26)