A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual Components
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Unified Dyskinesia Rating Scale (UDysRS)
研究概览
简要总结
This is a two-part, double-blind, placebo-controlled, randomized, multicenter Phase 2 clinical trial of JM-010 in patients with Parkinson's Disease.
详细描述
This is a two-part, Phase 2, double-blind, placebo-controlled, randomized, multicentre study.
Subjects with a diagnosis of PD and dyskinesias in PD will complete a Screening Visit to assess eligibility to participate in the study.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is able to read, understand, and provide written, dated informed consent prior to Screening Visit.
- •Is male or female, between 18 and 85 years of age at Screening Visit.
- •Is diagnosed with idiopathic PD that meets UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria
- •Has experienced dyskinesia
- •Has stable peak-effect dyskinesia
- •Has more than one hour of "ON" time with troublesome dyskinesia
排除标准
- •Has undergone surgery for the treatment of PD
- •Has a current diagnosis of Substance Use
- •Has psychiatric diagnosis of acute psychotic disorder or other psychiatric diagnoses
- •Has current seizure disorders requiring treatment with anticonvulsants.
- •Other criteria related to other medical conditions to be referred to the protocol.
研究组 & 干预措施
Part 1, JM-010 component Group B
Part 1, JM-010 component Group B
干预措施: Part 1, JM-010 component Group B (Drug)
Part 1, JM-010 component Group C
Part 1, JM-010 component Group C
干预措施: Part 1, JM-010 component Group C (Drug)
Part 1, JM-010 component Group A
Part 1, JM-010 component Group A
干预措施: Part 1, JM-010 component Group A (Drug)
Part 1, Placebo Group
Part 1, Placebo Group
干预措施: Part 1, Placebo Group (Drug)
Part 2, JM-010 combination Group A
Part 2, JM-010 combination Group A
干预措施: Part 2, JM-010 combination Group A (Drug)
Part 2, JM-010 combination Group B
Part 2, JM-010 combination Group B
干预措施: Part 2, JM-010 combination Group B (Drug)
Part 2, JM-010 component Group C
Part 2, JM-010 component Group C
干预措施: Part 2, JM-010 component Group C (Drug)
Part 2, Placebo Group
Part 2, Placebo Group
干预措施: Part 2, Placebo Group (Drug)
结局指标
主要结局
Unified Dyskinesia Rating Scale (UDysRS)
时间窗: Week 12
Unified Dyskinesia Rating Scale (Scoring range: 0-104), higher score indicates more severe dyskinesia
次要结局
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Week 12)