NCT03845387已完成2 期
A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
研究概览
简要总结
Objective of this study is to investigate the efficacy, safety and pharmacokinetics of KDT-3594 in patients with early Parkinson's disease without a concomitant medication of L-dopa.
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
- None
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
- •Japanese patients
- •Patients who are diagnosed with Parkinson's disease according to UK Parkinson's Disease society brain bank clinical diagnostic criteria
- •Patients with Parkinson's disease in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
排除标准
- •Patients who are suspected any parkinsonism except for idiopathic Parkinson's disease
- •Patients who underwent neurosurgical treatment (stereotaxic destruction, deep brain stimulation etc.) for PD, or patients for whom surgical treatment is scheduled during the study
- •Patients with a complication of obvious dementia, or patients with Mini-Mental State Examination (MMSE) score < 24 points
研究组 & 干预措施
KDT-3594
Experimental
干预措施: KDT-3594 (Drug)
Pramipexole
Other
Reference drug
干预措施: Pramipexole (Drug)
结局指标
主要结局
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
时间窗: 12 weeks
Change from baseline (Week 0) in MDS-UPDRS total score
次要结局
- Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score(12 weeks)
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39) score(12 weeks)
研究者
研究点 (1)
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