Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) During Pregnancy

Study Overview
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Brief Summary
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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 during pregnancy, as well as in 2 Ubrelvy-unexposed comparison groups. Ubrelvy (ubrogepant) is an approved drug for the acute treatment of migraine in adults. Approximately 560 pregnant women with migraine exposed to Ubrelvy and 560 pregnant women with migraine without exposure to Ubrelvy will be enrolled in this study in the United States. Participants enrolled in the Ubrelvy-exposed group will receive Ubrelvy as prescribed by their physician. There may be higher treatment burden for participants in this trial compared to their standard of care.

Official Title
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The Ubrelvy Pregnancy Exposure Registry: An Observational, Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) During Pregnancy

Conditions
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Migraine

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Within the United States. 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: adequate information to conclude that at least 1 dose of Ubrelvy was taken during pregnancy, including date(s) of administration. Unexposed women with migraine (treated or untreated): adequate information to conclude that she has never taken Ubrelvy or discontinued Ubrelvy at least 3 months prior the first day of last menstrual period (LMP). Exclusion Criteria: Documentation of exposure to any gepants (acute or preventive) other than Ubrelvy from 5 half-lives prior to the first day of LMP 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ubrelvy-Exposed Women With Migraine<br>Pregnant women with migraine who took at least 1 dose of Ubrelvy, the exposure of interest, at any time during pregnancy as part of routine care. | |
| Unexposed Women With Migraine<br>Pregnant women with migraine (treated and untreated) who have never taken Ubrelvy (i.e., before or during the enrolled pregnancy) or who have discontinued Ubrelvy at least 3 months prior to the first day of last menstrual period (LMP). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Congenital Malformations (MCMs) | An MCM is defined as any major structural or chromosomal defect in live born infants, stillbirths/fetal losses >=20 weeks gestation and elective terminations of any gestational age. | Up through the first 12 months of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Pregnant Participants Experiencing Spontaneous Abortion | Recognized spontaneous abortion (SAB): loss of an embryo/fetus due to natural causes prior to 20 weeks of gestation. | Up through the first 12 months of life | 
| Percentage of Pregnant Participants Experiencing Stillbirth | A fetal death occurring at 20 gestation weeks or greater, or if gestational age is unknown, a fetus weighing 350 g or more. | Up through the first 12 months of life | 
| Percentage of Pregnant Participants With Elective Termination | Elective termination is voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to abnormalities. | Up through the first 12 months of life | 
| Percentage of Pregnant Participants Experiencing Preeclampsia | Preeclampsia is the presence of hypertension on 2 occasions at least 4 hours apart after 20 weeks gestation (in a woman with a previously normal blood pressure) and proteinuria, or new-onset hypertension accompanied by thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual symptoms. | Up through the first 12 months of life | 
| Percentage of Pregnant Participants Experiencing Eclampsia | Eclampsia is defined as new-onset seizures (tonic-clonic, focal, or multifocal) in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use. | Up through the first 12 months of life | 
| Percentage of Pregnant Participants Experiencing Gestational Hypertension | Gestational hypertension is defined as high blood pressure (Elevated: systolic between 120-129 mm Hg and diastolic less than 80 mm Hg; Stage 1 hypertension: systolic between 130-139 mm Hg or diastolic between 80-89 mm Hg; Stage 2 hypertension: systolic at least 140 mm Hg or diastolic at least 90 mm Hg) associated with pregnancy. | Up through the first 12 months of life | 
| Percentage of Infants Experiencing Preterm Birth | Preterm birth is defined as an infant born at gestational age <37 weeks. | Up through the first 12 months of life | 
| Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth | SGA at birth based on health care provider (HCP) report, typically defined as birthweight <=10th percentile for sex and gestational age. | Up through the first 12 months of life | 
| Percentage of Infants Experiencing Minor Malformations | Minor malformations not previously reported. | Up through the first 12 months of life | 
| Percentage of Infants With Age-appropriate Infant Growth and Development | Age-appropriate progress on developmental milestones based on the overall assessment by the infant's HCP (e.g., appropriate or delayed) up to 1 year of age. | Up through the first 12 months of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Ubrelvy, Ubrogepant