Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT05158894
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05158894
Study Brief:
Protocol Section:
NCT05158894