The Ubrelvy and Qulipta Pregnancy Exposure Registry EMPRESS: An Observational, Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) and Qulipta (Atogepant) During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,884
- 试验地点
- 2
- 主要终点
- Major Congenital Malformations (MCMs)
研究概览
简要总结
Migraine is a common neurological disorder typically characterized by attacks of throbbing or pulsating headache on one side of the head of moderate to severe pain intensity. The purpose of this study is to evaluate fetal, maternal, and infant outcomes through 12 months of age among women exposed to Ubrelvy or Qulipta during pregnancy, as well as in 2 comparator groups.
Ubrelvy (ubrogepant) and Qulipta (atogepant) are approved drugs for the acute treatment of migraine in adults. Approximately 628 pregnant women with migraine exposed to Ubrelvy, 628 pregnant women with migraine exposed to Qulipta and 628 pregnant women with migraine in comparator group will be enrolled in this study in the United States.
Participants enrolled in the Ubrelvy-exposed group and Qulipta-exposed group will receive Ubrelvy and Qulipta respectively as prescribed by their physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Within the United States or Canada.
- •Qualify as a prospective enrollment, defined as currently pregnant.
- •A diagnosis of migraine by the patient's health care provider (HCP).
- •Provide contact information for the participant and her and her infant(s)', if applicable, HCPs.
- •Authorize their HCP(s) to release maternal and infant medical information to the registry, upon request.
- •Provide sufficient information to confirm eligibility for 1 of following:
- •Ubrelvy-exposed women with migraine: documented information indicating that at least 1 dose of Ubrelvy was taken during pregnancy, including the estimated number of administrations per trimester.
- •Qulipta-exposed women with migraine: documented information to indicating that at least 1 dose of Qulipta was taken during pregnancy, including start and stop date(s) of administration.
- •Internal comparator: Ubrelvy/Qulipta-unexposed pregnant women with migraine: documented information indicating that they have, a) never taken Ubrelvy and/or Qulipta, or b) discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception.
排除标准
- •Documentation of exposure to any gepants (acute or preventive) other than Ubrelvy and Qulipta, or CGRP monoclonal antibodies, from 5 halflives of the respective treatment prior to conception or at any point during pregnancy before enrollment.
- •Women who are no longer pregnant (retrospective cases women for whom the pregnancy has already ended, and the outcome of pregnancy is known at the time of enrollment).
- •For further clarification of inclusion/exclusion please contact the investigator to the end of this section in case anything is unclear to a potential patient, etc
结局指标
主要结局
Major Congenital Malformations (MCMs)
时间窗: Up through the first 12 months of life
An MCM is defined as any major structural or chromosomal defect in live born infants, stillbirths/fetal losses of any gestational age.
次要结局
- Percentage of Infants Experiencing Minor Malformations(Up through the first 12 months of life)
- Percentage of Pregnant Participants Experiencing Spontaneous Abortion(Up through the first 12 months of life)
- Percentage of Infants With Age-appropriate Infant Growth and Development(Up through the first 12 months of life)
- Percentage of Pregnant Participants Experiencing Stillbirth(Up through the first 12 months of life)
- Percentage of Pregnant Participants Experiencing Eclampsia(Up through the first 12 months of life)
- Percentage of Pregnant Participants Experiencing Gestational Hypertension(Up through the first 12 months of life)
- Percentage of Pregnant Participants Experiencing Gestational Diabetes(Up through the first 12 months of life)
- Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth(Up through the first 12 months of life)
- Percentage of Pregnant Participants With Elective Termination(Up through the first 12 months of life)
- Percentage of Pregnant Participants Experiencing Preeclampsia(Up through the first 12 months of life)
- Percentage of Infants Experiencing Preterm Birth(Up through the first 12 months of life)