NCT00203060已完成3 期
A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With Levodopa
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 主要终点
- The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks.
研究概览
简要总结
Study to look at the effectiveness, tolerability and safety of two doses of Study Medication in Early Parkinson's Disease (PD) Patients who have not been treated with Levodopa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, 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
- •Men and women with Parkinson's disease (PD) whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without other known or suspected cause of parkinsonism.
- •Subjects must be age 35 years or older.
- •Subjects not taking or requiring anti-parkinsonian medications, except for anticholinergics.
排除标准
- •Subjects with unstable systemic medical problems or clinically significant malignancy, with particular attention to clinically significant or unstable vascular disease
研究组 & 干预措施
A
Experimental
Rasagiline treatment
干预措施: Rasagiline Mesylate (Drug)
B
Placebo Comparator
placebo arm
干预措施: placebo (Drug)
结局指标
主要结局
The primary objective is to assess the safety and efficacy of rasagiline in PD subjects, not receiving or requiring carbidopa/levodopa therapy. The primary efficacy measure will be the change in total UPDRS score, calculated from baseline to 26 weeks.
时间窗: 58 weeks
次要结局
未报告次要终点
研究者
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