A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 459
- 主要终点
- Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
研究概览
简要总结
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
详细描述
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject has completed the treatment period of a previous blinded study of pimavanserin
- •The subject is willing and able to provide consent
- •Caregiver is willing and able to accompany the subject to all visits
排除标准
- •Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
- •Subject is judged by the Investigator to be inappropriate for the study
研究组 & 干预措施
Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
干预措施: Pimavanserin tartrate (ACP-103) (Drug)
结局指标
主要结局
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
时间窗: From first to last study drug dose plus 30 days
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
次要结局
未报告次要终点