Recruiting

Ubrogepant & Atogepant

Sponsor:

AbbVie

Code:

NCT05158894

Conditions

Migraine

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Migraine

Study ID

NCT05158894

Start date

Jan 10, 2023

Status verified date

Dec, 2025

Completion date

Jan, 2036

Anticipated

Primary completion date

Jan, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

1884 participants

Anticipated

Interventions and Outcome Measures

Arms

Ubrelvy-Exposed Women With Migraine

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.

Qulipta-Exposed Women With Migraine

Pregnant women with migraine who took at least 1 dose of Qulipta, the exposure of interest, at any time during pregnancy as part of routine care.

Ubrelvy/Qulipta-Unexposed Women With Migraine

Pregnant women with migraine who have never taken Ubrelvy and/or Qulipta, OR discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception.

Primary outcome measure

  • Major Congenital Malformations (MCMs) [ Time Frame: Up through the first 12 months of life ]

Central Contacts and Locations

Central contacts

EMPRESS Pregnancy Call Center

833-782-7241empresspregnancyregistry@iqvia.com

Locations

Iqvia /Id# 266904

Recruiting

Durham, North Carolina, United States, 27703-8426

Ottawa Hospital Research Institute /ID# 280174

Recruiting

Ottawa, Ontario, Canada, K1Y 4E9

Contacts

Site Coordinator

8444670844empressstudycanada@ohri.ca

More Information

Sponsor

AbbVie

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Keywords

  • Migraine
  • Ubrelvy
  • Ubrogepant
  • Atogepant
  • Qulipta
  • MED-EPI-NEU-0649

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2025-12-15.