NCT01174004已完成3 期
A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 199
- 主要终点
- Antipsychotic Efficacy
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of 40 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
- •Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
- •Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
- •Subjects that are on anti-Parkinson's medication must be on a stable dose for 1 month prior to Study Day 1 (Baseline) and during the trial
- •Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
- •The subject is willing and able to provide consent
- •Caregiver is willing and able to accompany the subject to all visits
- •Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment
排除标准
- •Subject has a 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
- •Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
- •Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
- •Subject has had a myocardial infarction in last six months
- •Subject has any surgery planned during the screening, treatment or follow-up periods
- •Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).
研究组 & 干预措施
1
Experimental
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
干预措施: pimavanserin tartrate (Drug)
2
Placebo Comparator
placebo, tablet, once daily by mouth for 6 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Antipsychotic Efficacy
时间窗: Each study visit (i.e. Days 1, 15, 29 and 43)
Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement. Analysis Method: Mixed Model Repeated Measures (MMRM)
次要结局
- Motor Symptoms Change From Baseline (Negative = Improvement)(Study Days 1 and 43)
研究者
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