Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in Korea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 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
To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily OFF time during 18 weeks of treatment in levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.
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 Azilect®, a monoamine oxidase type B (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. Azilect® is approved for treatment of PD in Europe and the US.
The objective of this study is to evaluate the efficacy, tolerability, and safety of Azilect® compared to placebo in Korean 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
- 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 (not including morning akinesia)
- •Patients with a Modified Hoehn and Yahr stage <5 in the OFF state
- •Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at least 14 days prior to baseline
- •Patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
- •Patient 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 taking any disallowed medication according to the Azilect® approved label
- •Patients taking MAO inhibitors within 3 months prior to baseline visit
- •Patients with a known serious adverse reaction to selegiline
- •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 <=24
- •Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Azilect®
干预措施: Azilect® (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 6, 10, 14, and 18
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 6, 10, 14 and 18, and the Baseline Total Daily OFF Time.
次要结局
- Clinical Status Using CGI-I Score During ON Time(Week 18)
- Change From Baseline in UPDRS-ADL Score During OFF Time(Baseline and Week 18)
- Change From Baseline in UPDRS Motor Score During ON Time(Baseline and Week 18)