NCT00406588已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.
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
- 295
- 试验地点
- 87
- 主要终点
- Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.
研究概览
简要总结
This study is a multicenter, randomized, double blind, parallel group study of 3 months' treatment with SLV308 administered as a monotherapy in patients with advance 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,
- •advance stage of disease,
- •Modified Hoehn & Yahr stage II-IV,
- •presence of a recognizable 'on' and 'off' state (motor fluctuations) and stable treatment with levodopa for at least 28 days prior to randomization
排除标准
- •'on-off' phenomena or 'yo-yoing' and/or an abrupt unpredictable loss of efficacy unrelated to the timing of L-DOPA administration,
- •Prevalent expression of troublesome dyskinesias during 'on' time at waking hours,
- •Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists,
- •Previous surgery for the treatment of PD
研究组 & 干预措施
1
Experimental
干预措施: Levodopa (Pardoprunox) (Drug)
2
Placebo Comparator
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Change from baseline to end of the maintenance period or at the early termination visit in 'off'-time as recorded in patients' home diaries.
时间窗: 12 weeks
次要结局
- Increase of 'on'-time, change from baseline in the total score of the UPDRS part 2+3, and PDQ-39(12 weeks)
研究者
研究点 (87)
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