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NCT05158894 | Recruiting | Migraine

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

AbbVie

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.

Condition or disease

Migraine

Study Type : Observational
Estimated Enrollment : 1884 participants
Official Title : The Ubrelvy and Qulipta Pregnancy Exposure Registry (EMPRESS): An Observational Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) and Qulipta (Atogepant) During Pregnancy
Actual Study Start Date : January 10, 2023
Estimated Primary Completion Date : September 29, 2034
Estimated Study Completion Date : September 29, 2034

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
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 half-lives 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
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy

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

How to Participate

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Locations

Recruiting

United States, North Carolina

Iqvia /Id# 244683

Durham, North Carolina, United States, 27703-8426