NCT00269516已完成3 期
A Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease
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
- 468
- 试验地点
- 128
- 主要终点
- UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
研究概览
简要总结
This study is a multicenter, randomized, double blind, parallel group study of 6 months' treatment with SLV308 administered as a monotherapy in patients with early stage PD. An open label safety extension to this study is planned as a separate protocol for patients who are willing and eligible to participate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of idiopathic Parkinson's Disease,
- •Early stage of disease, Modified Hoehn & Yahr up to stage III,
- •UPDRS motor score (part III) 10 at baseline.
排除标准
- •Diagnosis is unclear or a suspicion of other parkinsonian syndromes,
- •Patients who have undergone surgery for the treatment of PD,
- •Presence of dyskinesias,
- •Motor fluctuations or loss of postural reflexes,
- •Clinically significant abnormalities,
- •Patients treated with L-dopa or dopamine agonists currently or in the past (for more than 3 months in total),
- •Antipsychotic.
研究组 & 干预措施
1
Experimental
干预措施: Pardoprunox (Drug)
2
Experimental
干预措施: Pardoprunox (Drug)
3
Experimental
干预措施: Pardoprunox (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
UPDRS part 3 (motor score)and change from baseline to 24 weeks maintenance treatment
时间窗: 6 months
次要结局
- UPDRS part 2 (ADL score); CGI-Improvement; PDQ-39 total score: all change from baseline to 24 weeks maintenance treatment(6 months)
研究者
研究点 (128)
Loading locations...
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