NCT00314288已完成2 期
A Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced Dyskinesia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 360
- 试验地点
- 51
研究概览
简要总结
The primary purpose of the study is to investigate the anti-dyskinetic effect of several doses of sarizotan in Parkinson patients in order to generate information on the dose-response relationship (dose-finding).
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •The subject is an out-patient
- •Age 30 years or above
- •Dyskinesias present during more than 25% of the waking day
- •Dyskinesias at least moderately disabling
- •Written informed consent
排除标准
- •Pregnancy and/or lactation
- •Participation in another study within the last 30 days
- •Dementia or other psychiatric illness that prevents provision of informed consent
- •History of allergic disorders such as asthma
- •Known hypersensitivity to the study treatment(s)
- •Known hypersensitivity to ACTH
研究者
研究点 (51)
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