A Long-term, Open-label Extension Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 168
- 试验地点
- 60
- 主要终点
- Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions
研究概览
简要总结
To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS
详细描述
This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present 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
- 5 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302
- •Met all entry criteria for the antecedent study
- •May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator.
- •Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits.
排除标准
- •History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary.
- •Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder
- •History of suicide attempt or inpatient psychiatric hospitalization
- •Has a clinically significant abnormality in vital signs at Baseline
- •Has an average QTcF interval of >450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)
- •Has developed a clinically significant ECG finding during the antecedent study
- •Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study
- •Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
研究组 & 干预措施
Drug: Carbetocin
Carbetocin nasal spray 3.2 mg three times daily (TID)
干预措施: Carbetocin (Drug)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), withdrawals due to adverse events (AEs), potentially clinically important changes in other safety assessments, device incidents or device malfunctions
时间窗: Baseline to 36 months
Treatment-emergent adverse events (TEAEs) and device incidents or device malfunctions, TEAEs leading to discontinuation, TEAEs related to study drug, TEAEs by maximum severity, fatal TEAEs, treatment-emergent SAEs, and treatment-emergent SAEs related to study drug will all be summarized for all subjects as well as by previous treatment group.
次要结局
未报告次要终点