NCT03257046已完成1 期
A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of patients with reported or observed treatment-related adverse events
研究概览
简要总结
This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.
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
- •Clinical diagnosis of idiopathic Parkinson's disease (PD)
- •Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3
- •Maintenance on stable PD therapy
排除标准
- •Clinical signs of dementia
- •Suicidal ideation or behavior
- •Considered medically inappropriate for study participation
研究组 & 干预措施
1 mg ITI-214
Experimental
Administered once daily for 7 days
干预措施: ITI-214 (Drug)
3 mg ITI-214
Experimental
Administered once daily for 7 days
干预措施: ITI-214 (Drug)
10 mg ITI-214
Experimental
Administered once daily for 7 days
干预措施: ITI-214 (Drug)
30 mg ITI-214
Experimental
Administered once daily for 7 days
干预措施: ITI-214 (Drug)
90 mg ITI-214
Experimental
Administered once daily for 7 days
干预措施: ITI-214 (Drug)
Placebo
Placebo Comparator
Administered once daily for 7 days
干预措施: Placebo (Other)
结局指标
主要结局
Number of patients with reported or observed treatment-related adverse events
时间窗: 7 days
Safety and tolerability
次要结局
- Maximum Plasma Concentration (Cmax)(7 days)
- Area of the Curve (AUC)(7 days)
- Motor and non-motor symptoms as assessed by the MDS-UPDRS(7 days)
研究者
研究点 (2)
Loading locations...
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