NCT02939391已完成2 期
An Early Phase 2 Study of KW-6356 in Subject 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
- 175
- 主要终点
- Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
研究概览
简要总结
The primary objective is to evaluate the effect of KW-6356 on motor symptoms in Parkinson's disease and the primary endpoint is the change from baseline in the MDS-UPDRS part III score between KW-6356 and placebo in subjects with early Parkinson's disease in Japan.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject fulfills the UK Parkinson's Disease Society brain bank clinical diagnostic criteria
- •Parkinson's disease patients in Stages 1 to 3 on the Modified Hoehn and Yahr Scale
- •MDS-UPDRS part III score of ≥ 15
排除标准
- •Use of any CYP3A4/5-related drugs within 2 weeks prior to enrollment.
- •Use of any of the specified antiparkinsonian drugs and dopamine antagonists during the specified period.
- •Treatment with levodopa/DCI at any time in the past for a period of 4 weeks or more.
- •Neurosurgical operation for Parkinson's disease (stereotactic surgery, deep brain stimulation or gamma knife), or treatment by transcranial magnetic stimulation (TMS).
- •Either of the following criteria consecutively at screening and enrollment;
- •Resting Pulse > 100 bpm
- •Resting systolic blood pressure > 140 mmHg, or diastolic blood pressure > 90 mmHg
- •Significant dementia or a Mini-Mental State Examination (MMSE) score of ≤
- •Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline.
- •Anyone otherwise considered unsuitable for the study by the investigator or sub-investigator including those who are unable to communicate or to cooperate with the investigator or sub-investigator.
研究组 & 干预措施
KW-6356 Low Dose
Experimental
Oral administration
干预措施: KW-6356 (Drug)
KW-6356 High Dose
Experimental
Oral administration
干预措施: KW-6356 (Drug)
Placebo
Placebo Comparator
Oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the Movement disorder society-unified Parkinson's disease rating scale(MDS-UPDRS) partⅢ score
时间窗: Up to 12 weeks after dosing
次要结局
- Clinical global impression-improvement(CGI-I) score(Week 12)
- Patient global impression-improvement(PGI-I) score(Week 12)
- Change from baseline in the Parkinson's disease questionnaire-39(PDQ-39) total scores(Up to 12 weeks after dosing)
- Change from baseline in the MDS-UPDRS subitem and total scores(Up to 12 weeks after dosing)
- Number and percentage of subjects with treatment-emergent adverse events(Up to 14 weeks after dosing)
- Profiles of pharmacokinetics of plasma KHK6356 concentration(2, 4, 8 and 12 weeks after dosing)
研究者
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