SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,731
- 试验地点
- 2
- 主要终点
- Long-term Safety
研究概览
简要总结
The SUNOSI (solriamfetol) Pregnancy Registry is a prospective, multi-country, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).
详细描述
The goal of the registry is to provide information on the safety of solriamfetol during pregnancy so that patients and physicians can weigh the benefits and risks of exposure during pregnancy and make informed treatment decisions.
The study collects health information from enrolled pregnant women and their healthcare providers related to their pregnancies and developing babies up to 1 year of age. The registry is strictly observational. Only data that are routinely documented in patients' medical records during the course of usual care will be collected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women of any age
- •Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy
- •Resident of a country where solriamfetol is available for the treatment of excessive daytime sleepiness (EDS) associated with narcolepsy or OSA
- •Provides written informed consent to participate in the study
- •Authorization for her HCP(s) to provide data to the registry
排除标准
- •Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)
- •Inclusion of a prior pregnancy in the main analysis population
研究组 & 干预措施
Cohort 1: Solriamfetol-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
干预措施: Sunosi (solriamfetol) (Drug)
Cohort 2: Unexposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
干预措施: No treatment (Other)
Cohort 3: Other-exposed participants with narcolepsy or OSA
Pregnant women with a diagnosis of narcolepsy or OSA
干预措施: Other prescription wake-promoting medications or stimulants (Drug)
Cohort 4: Solriamfetol-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
干预措施: Sunosi (solriamfetol) (Drug)
Cohort 5: Other-exposed participants without narcolepsy or OSA
Pregnant women without a diagnosis of narcolepsy or OSA
干预措施: Other prescription wake-promoting medications or stimulants (Drug)
结局指标
主要结局
Long-term Safety
时间窗: Baseline up to 12 months after pregnancy outcome
次要结局
未报告次要终点