Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 18
- 主要终点
- Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
研究概览
简要总结
The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety of rasagiline compared to placebo in levodopa-treated Parkinson's Disease (PD) Chinese patients with motor fluctuations. Azilect® (Rasagiline) is indicated for the treatment of idiopathic PD as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
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
- 30 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 motor fluctuations averaging at least 1 hour daily in the "OFF" state during the waking hours.
- •Patients with a Modified Hoehn and Yahr stage ≤3 in the "ON" state.
- •Patients taking optimised levodopa or dopa decarboxylase inhibitor (DDI) therapy; they must be stable for at least 14 days prior to baseline.
- •Patients receiving at least 3 daily doses of levodopa and not more than 8 daily doses of levodopa.
- •Patients who have demonstrated the ability to keep accurate "24-hour" diaries prior to randomisation.
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 who have undergone a neurosurgical intervention of PD.
- •Patients with severe disabling dyskinesias.
- •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
Azilect®
干预措施: Azilect® (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary
时间窗: Baseline and Weeks 4, 8, 12, and 16
Parkinson's Disease Patient Diary is a self-administered diary designed to assess motor fluctuations throughout the day. It is divided into 30-minute intervals, and the patient selects one of four options for each interval: asleep; off; on with no dyskinesia or without troublesome dyskinesia; or on with troublesome dyskinesia. The Change From Baseline in Mean Total Daily OFF time is calculated by taking the difference between the average of the total daily OFF time at Weeks 4, 8, 12, and 16, and the Baseline Total Daily OFF Time.
次要结局
- Change From Baseline in UPDRS Motor Score During ON Time(Baseline and Week 16)
- Change From Baseline in UPDRS-ADL Score During OFF Time(Baseline and Week 16)
- Clinical Status Using CGI-I Score During ON Time(Week 16)