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

NCT05158894 | Recruiting

• 2 other identifiers: P22-392MED-EPI-NEU-0649
• Study Type: observational
• Target: 1,884
• Locations: 2 countries
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major Congenital Malformations (MCMs)

  An MCM is defined as any major structural or chromosomal defect in live born infants, stillbirths/fetal losses of any gestational age.

  Up through the first 12 months of life

Secondary Outcomes (11)

• Percentage of Pregnant Participants Experiencing Spontaneous Abortion

  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 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 Pregnant Participants Experiencing Eclampsia

  Up through the first 12 months of life

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of pregnant women, residing in the US and at least 18 years of age, and live born infants resulting from enrolled pregnancies. Participating women must meet eligibility criteria, including criteria for either the exposure or comparator group.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

Iqvia /Id# 266904

Durham, North Carolina, 27703-8426, United States

RECRUITING

Ottawa Hospital Research Institute /ID# 280174

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

EMPRESS Pregnancy Call Center

CONTACT

833-782-7241; empresspregnancyregistry@iqvia.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: January 10, 2023
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1); CA (1)