NCT00174239终止4 期
A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 220
- 试验地点
- 15
- 主要终点
- PDSS, UPDRS
研究概览
简要总结
The study will assess the relative benefit of cabergoline vs carbidopa/levodopa therapy in treating nighttime problems of Parkinson Disease.
详细描述
The trial was terminated prematurely June 26, 2005 due to the inability to re-supply study drug for the planned number of subjects. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson Disease
- •Must be experiencing sleep akinesia
排除标准
- •Current treatment with other dopamine agonists
- •Nocturnal hallucinations
结局指标
主要结局
PDSS, UPDRS
次要结局
- CGI, PGI, Epworth Sleepiness Scale, PDQ-39
研究者
研究点 (15)
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