NCT00407212已完成1 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's Disease
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 301
- 试验地点
- 45
- 主要终点
- Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator
研究概览
简要总结
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
详细描述
This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ,aged 30-80 years
- •Clinical diagnosis of early stage idiopathic Parkinson's disease
- •Experiencing two of the three following signs; bradykinesia, rigidity, and tremor
- •Not currently taking any antiparkinson medication
排除标准
- •A history of alcohol or drug abuse in the past year
- •A diagnosis psychiatric illness
- •Patients who currently are taking MAO inhibitors within 30 days of entering the study
- •Patients who are hypersensitive to selegiline, MAO-B inhibitors, or tricyclic antidepressants
- •Additional inclusion/exclusion criteria may apply
结局指标
主要结局
Time to the need for symptomatic treatment with dopaminergic agents", defined as the number of days from the first dose of TCH346 study treatment to the date when it symptomatic treatment is required as determined by the investigator
Safety assessments as based on the frequency of adverse events and the number of laboratory values that fall outside of the ranges.
次要结局
- Annual change rates for Unified Parkinsons Disease Rating Scalescore
- Changes in UPDRS score after 4 weeks and after withdrawal of study treatment
- Percentage of patients needing symptomatic treatment within 12 months
研究者
研究点 (45)
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