An Open-label, Sequential Cohorts, Flexible Dose Study to Evaluate the Tolerability, Safety and Pharmacokinetics of Iloperidone in Elderly Patients With Parkinson's Disease Psychosis (PDP)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.
研究概览
简要总结
This is an open-label, sequential cohorts, flexible dose study to evaluate the tolerability, safety and pharmacokinetics of iloperidone in elderly patients with Parkinson's disease psychosis (PDP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide consent and willing to complete all aspects of the study.
- •Male or female patients greater or equal to 65 years of age.
- •Clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year
- •Psychotic symptoms for at least one month and actively experiencing psychotic symptoms each week during the month prior to screening
排除标准
- •History of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
- •Current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study
研究组 & 干预措施
Iloperidone (Cohort 1)
干预措施: Iloperidone (Drug)
Iloperidone (Cohort 2)
干预措施: Iloperidone (Drug)
结局指标
主要结局
Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.
时间窗: 8 days and 5 weeks
As measured by plasma concentrations.
Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis.
时间窗: 8 days and 5 weeks
As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs.
Reduction in positive symptoms of Parkinson's disease psychosis.
时间窗: 8 days and 5 weeks
As measured by the Scale for the Assessment of Positive Symptoms for Parkinson's Disease Psychosis (SAPS-PD).
次要结局
未报告次要终点