Open-Label Extension Study of JM-010 in Parkinson's Disease Patients With Dyskinesia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
研究概览
简要总结
This current open-label extension (OLE) study (JM-010CS-OL) will explore the safety and tolerability of long-term administration of JM-010 of patients who completed 12-week treatment of Phase 2 (JM-010CS03) study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 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.
- •Subjects will be deemed likely to comply with study protocol and communicate with study personnel about adverse events (AEs) and other clinically important information.
- •Completed study visits per protocol in a previous JM-010CS03 study.
- •Ambulatory or ambulatory-aided (e.g. walker or cane) ability while ON, such that the subject can complete study assessments;
- •Knowledgeable and reliable caregiver/study partner, if appropriate, to accompany the subject to perform study visits and assist in completion of study instruments, as needed and allowed;
- •The subject himself/herself wishes to continue taking JM-010, and the investigator deems continued administration to be necessary or appropriate.
排除标准
- •Discontinued study drug in a previous JM-010 Dyskinesia efficacy study due to intolerable or unacceptable AEs considered to be related to JM-
- •Has other psychiatric (not including hallucinations due to side effects of dopamine therapy), neurological or behavioral disorders that in the opinion of the investigator may interfere with the conduct or interpretation of the study, including dementia, or subject who is considered violent.
- •Has a significant risk for suicidal behavior in the opinion of the investigator during the course of their participation in the study or
- •At Screening Visit: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C-SSRS with reference to a 6-month period prior to Screening Visit; or
- •At Screening Visit: the subject has had 1 or more suicidal attempts with reference to a 2 year period prior to Screening Visit; or
- •At Baseline Visit: the subject scores "yes" on items 4 or 5 in the Suicidal Ideation section of the C SSRS with reference to Screening Visit
- •Has current seizure disorders (other than febrile seizures in childhood) requiring treatment with anti convulsants.
研究组 & 干预措施
High dose
JM-010 fixed combination drug (Group A) will be administered orally.
干预措施: JM-010 (Drug)
Low dose
JM-010 fixed combination drug (Group B) will be administered orally.
干预措施: JM-010 (Drug)
结局指标
主要结局
Incidence of clinically significant ECG abnormalities (Safety and Tolerability)
时间窗: Baseline to Week 48
12-lead electrocardiogram (ECG) assessments: Q-Tc interval in msec
Incidence of clinically significant cardiovascular abnormalities (Safety and Tolerability)
时间窗: Baseline to Week 48
Blood pressure in mmHg
Incidence of suicidal ideation or suicidal behavior (Safety and Tolerability)
时间窗: Baseline to Week 48
Columbia Suicide Severity Rating Scale (C-SSRS): Score ranges is 0- 50, where a higher score means more severe suicial ideation or behavior
次要结局
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Baseline to Week 48)