NCT00212693已完成2 期
Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in Japan
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 165
- 主要终点
- Unified Parkinson's disease rating scale (Part III)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ONO-2506PO in patients with Parkinson's Disease
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease
- •Stage 2 - Stage 4 of revised Hoehn & Yahr severity score
- •Taking L-dopa/DCI without changing dose and regimen
- •Having motor complication
- •Other inclusion criteria as specified in the study protocol
排除标准
- •Previous participation in ONO-2506PO or ONO-2506 protocol
- •Previous brain surgery for Parkinson's disease
- •Presence or history of serious cardiac disease
- •Other exclusion criteria as specified in the study protocol
结局指标
主要结局
Unified Parkinson's disease rating scale (Part III)
次要结局
- Unified Parkinson's disease rating scale (Part I, II, IV and total), revised Hoehn & Yahr severity score and off time
研究者
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