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Observational Study of Ubrelvy or Qulipta Use During Pregnancy for Migraine

This study is looking at the effects of Ubrelvy (ubrogepant) or Qulipta (atogepant) when taken by pregnant women for migraine. These are approved medications for migraine. Researchers want to understand how these drugs affect the mother, the baby during pregnancy, and the baby up to 12 months after birth. They will compare women who took Ubrelvy or Qulipta with other pregnant women with migraine who did not take these specific drugs. The main goal is to see if there are any major birth defects. You could join if you are pregnant, have migraine, and live in the United States or Canada.

Study design
This is an observational study involving approximately 1884 pregnant women with migraine. It will compare outcomes in women exposed to Ubrelvy or Qulipta with two other groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants and their infants will be followed up through the first 12 months of the infant's life.

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NCT05158894

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

Recruiting
Not specifiedAges 18+Observational
AbbVie
~1,884 participants
Updated 2025-12-15 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major Congenital Malformations (MCMs)
Measured over Up through the first 12 months of life

Conditions

Migraine

Explore related trials

Migraine

Where it's being run

2 sites across 2 states
North Carolina1
Ontario1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

EMPRESS Pregnancy Call Center
[email protected]
833-782-7241
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Major Congenital Malformations (MCMs)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.