NCT00335374已完成3 期
An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD Patients
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
- 202
- 试验地点
- 75
- 主要终点
- Safety: laboratory data, adverse events, vital signs, ECG
研究概览
简要总结
This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.003 trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who have completed S308.3.003 trial
排除标准
- •Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.003
研究组 & 干预措施
1
Experimental
干预措施: Pardoprunox (Drug)
结局指标
主要结局
Safety: laboratory data, adverse events, vital signs, ECG
时间窗: 24 weeks
次要结局
- UPDRS parts 1, 2 and 3, CGI-severity, CGI-Improvement, PDQ-39 total score: all change from baseline(24 weeks)
研究者
研究点 (75)
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