A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 513
- 试验地点
- 77
- 主要终点
- Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score.
研究概览
简要总结
This study consists of 2 parts. Part 1 of the study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy. Part 2 is an optional long term extension study for subjects who have completed week 40 of Part 1
详细描述
This study is designed to assess the ability of K0706 to slow the progression of PD. Preclinical animal model data have already demonstrated that K0706 has neuroprotective activity, but further development will require human clinical experience.
This study will also allow determination of safety and tolerability of K0706 over many months in subjects with PD.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
K0706, low dose
干预措施: K0706 (Drug)
K0706, high dose
干预措施: K0706 (Drug)
Placebo
干预措施: placebo (Other)
结局指标
主要结局
Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score.
时间窗: Week 40
Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.
Number of Participants With Treatment-emergent Adverse Events
时间窗: Part 2 (Week 40 to 80)
次要结局
- Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Part II and Part III Total Scores and Part 2: Change From Week 40 to Week 76 in the MDS-UPDRS Part III Total Score.(Part 1: Week 40 and Part 2: Week 76)
- To Determine if K0706 Delays the Initiation of Symptomatic Medications in Participants(Part 1: Week 40 and Part 2: Week 80 (Part 2 is applicable to the subjects who complete the EoT visit of part 1 (V11/Week 40) and who confirm their willingness to participate in part 2 of the study.)
- Change in Health Related Quality of Life as Measured by the European Quality of Life Questionnaire 5 Level Version(Week 40)
- Change in Clinician Global Impression Severity(Week 40)
- Change in the Scales for Outcomes in Parkinson's Disease - Autonomic Questionnaire(Week 40)
- Serum Concentration Level of K0706(Week 28)