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

Launched by ABBVIE · Dec 2, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of two migraine treatments, Ubrelvy and Qulipta, for pregnant women. The study aims to understand how these medications affect both the mother and her baby during pregnancy and up to the baby's first year of life. To do this, researchers will enroll about 1,884 pregnant women in total: some will be taking Ubrelvy, others will be taking Qulipta, and a third group will not have used either medication.

To participate, women must be currently pregnant and diagnosed with migraines. They should also be living in the U.S. or Canada and able to provide their healthcare provider's contact information. Participants in the medication groups will take the drugs as prescribed by their doctors, while those in the comparison group must not have taken Ubrelvy or Qulipta recently. This study is currently recruiting participants, and it’s important for interested women to check if they meet the eligibility requirements, as well as to ask any questions they might have about the trial.

Gender

FEMALE

Eligibility 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 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