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

Last updated: January 9, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Headaches

Oral Facial Pain

Pain (Pediatric)

Treatment

N/A

Clinical Study ID

NCT05158894
P22-392
MED-EPI-NEU-0649
P22-392
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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)', ifapplicable, HCPs.

  • Authorize their HCP(s) to release maternal and infant medical information to theregistry, upon request.

  • Provide sufficient information to confirm eligibility for 1 of following:

  • Ubrelvy-exposed women with migraine: documented information indicating that atleast 1 dose of Ubrelvy was taken during pregnancy, including the estimatednumber of administrations per trimester.

  • Qulipta-exposed women with migraine: documented information to indicating thatat least 1 dose of Qulipta was taken during pregnancy, including start and stopdate(s) of administration.

  • Internal comparator: Ubrelvy/Qulipta-unexposed pregnant women with migraine:documented information indicating that they have, a) never taken Ubrelvy and/orQulipta, or b) discontinued Ubrelvy 2 days prior or Qulipta 5 days prior toconception.

Exclusion

Exclusion Criteria:

  • Documentation of exposure to any gepants (acute or preventive) other than Ubrelvyand Qulipta, or CGRP monoclonal antibodies, from 5 halflives of the respectivetreatment prior to conception or at any point during pregnancy before enrollment.

  • Women who are no longer pregnant (retrospective cases women for whom the pregnancyhas already ended, and the outcome of pregnancy is known at the time of enrollment).

  • For further clarification of inclusion/exclusion please contact the investigator tothe end of this section in case anything is unclear to a potential patient, etc

Study Design

Total Participants: 1884
Study Start date:
January 10, 2023
Estimated Completion Date:
September 30, 2034

Connect with a study center

  • Iqvia /Id# 244683

    Durham, North Carolina 27703-8426
    United States

    Active - Recruiting

  • Iqvia /Id# 266904

    Durham, North Carolina 27703-8426
    United States

    Active - Recruiting

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