NCT02439203已完成2 期
A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010
Bukwang Pharmaceutical0 个研究点目标入组 30 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS)
研究概览
简要总结
The purpose of a randomized, double-blind, placebo-controlled, 2-way crossover study is to evaluate the efficacy, safety/tolerability and pharmacokinetics of JM-010 for the treatment of subjects with Parkinson's Disease (PD) with levodopa-induced dyskinesia (LID).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Subject with a diagnosis of moderate to severe idiopathic PD with showing responsiveness to levodopa.
- •All anti-Parkinsonian medications and levodopa must be stable for at least 1 week prior to the start of the run-in period.
- •Subject with stable predictable peak-effect LID of at least 2 hours of the awake day and with at least moderately disabling.
- •Amantadine and/or monoamine oxidase (MAO) inhibitor must be stopped at least 2 weeks prior to the start of Treatment Period 1(TP 1).
排除标准
- •Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism, Parkinson-plus syndromes or other neurological degenerative diseases.
- •History of any other brain surgery or surgery for the treatment of PD.
- •Current primary psychiatric diagnosis of acute psychotic disorder or other primary psychiatric diagnoses.
- •A history of psychosis and/or treatment with antipsychotics within 3 months prior to the start of Treatment Period 1(TP1).
- •A history of, or current, seizure disorders and subjects requiring treatment with anti-convulsants.
- •Clinically significant abnormal laboratory data at screening.
- •Clinically relevant ischemic heart symptoms or history of myocardial infarction, coronary artery bypass surgery or percutaneous transluminal coronary angioplasty, within the previous 12 months prior to the start of TP
- •History of cerebrovascular accident or transient ischemic attack, coronary vasospasm/Prinzmetal's angina.
- •History of serotonin syndrome.
- •Breast feeding or pregnant women.
研究组 & 干预措施
JM-010
Experimental
JM-010
干预措施: JM-010 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Investigator-rated change in dyskinesia severity as assessed by the Abnormal Involuntary Movement Scale (AIMS)
时间窗: 7 Days
Investigator-rated change in dyskinesia severity as assessed by the AIMS after levodopa challenge
次要结局
- Investigator-rated Parkinsonian disability using Unified Parkinson's Disease Rating Scale (UPDRS) Part III(7 Days)
- Subject-rated change in PD effects as assessed through daily Dyskinesia Questionnaires(Daily)
- Subject-rated change in dyskinesia severity as assessed by the Clinical Global Impression (CGI) scale(7 Days)
- Safety and Tolerability as measured by assessment of abnormalities in physical examinations, safety laboratory examinations, 12-lead electrocardiogram (ECG) and vital signs; collection of adverse events (AEs)(28 Days)
研究者
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