Assessment of Safe-use Conditions for Administration of ZULRESSO in a Home Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
研究概览
简要总结
The primary purpose of this study was to evaluate whether the safe-use conditions for administration of brexanolone (ZULRESSO®) can be implemented in a home setting.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ambulatory female ≥18 years of age.
- •Participant has a current diagnosis of postpartum depression (PPD), as confirmed by the investigator.
- •Participant agrees not to be the primary caregiver of any dependents during the infusion and must be accompanied by another adult (other than the home healthcare provider) during interactions with their child(ren).
- •Participant has no history of sleep apnea or any clinically significant respiratory conditions.
- •Participant agrees to refrain from the use of central nervous system depressants, such as opioids, benzodiazepines, sleep aids and from drinking alcohol during the infusion.
- •Participant is suitable for administration of ZULRESSO® in a home setting, as per the judgement of the investigator.
- •Participant's home is suitable and has necessary provisions for administration of ZULRESSO® and meets the following criteria:
- •safe environment for the home infusion provider staff.
- •access to a working telephone.
- •electricity and grounded electrical outlets.
- •running water.
- •access to back-up emergency services (911 service or ambulance availability).
- •sanitary environment.
- •Participant agrees to stay at home until the end-of-study visit has been completed, except for a medical emergency.
- •Participant must have a negative pregnancy test at screening and on Day 1 prior to the start of the ZULRESSO® infusion.
排除标准
- •Participant has end stage renal failure.
- •Participant has known allergy to progesterone or allopregnanolone or any excipients in the brexanolone injection.
- •Participant is currently at risk of suicide, as judged by the investigator, or has attempted suicide associated with the current episode of PPD.
研究组 & 干预措施
ZULRESSO®
Participants received a 60-hour single continuous intravenous (IV) infusion of ZULRESSO®, at 30 micrograms per kilogram per hour (mcg/kg/hour) (0 to 4 hours), at 60 mcg/kg/hour (4 to 24 hours), at 90 mcg/kg/hour (24 to 52 hours), followed by a dose taper to 60 mcg/kg/hour (52 to 56 hours), and 30 mcg/kg/hour (56 to 60 hours) during the study.
干预措施: ZULRESSO® (Drug)
结局指标
主要结局
Percentage of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) Leading to Dose Interruption/Discontinuation
时间窗: Up to Day 3
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered with a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with onset after the start of investigational product, or any worsening of a preexisting medical condition/AE with onset after the start of investigational product and throughout the study. Percentages are rounded off to the nearest single decimal.
次要结局
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)(Up to Day 3)
- Percentage of Participants With Medication Error(At screening and during the study (Up to Day 3))
- Percentage of Participants With Nonadherence With the Safe-Use Conditions for Administration of ZULRESSO®(Up to Day 3)
- Number of Use-Related Issues Related to the Home Administration of ZULRESSO®(Up to Day 3)