NCT05158894 Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
| NCT ID | NCT05158894 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AbbVie |
| Condition | Migraine |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,884 participants |
| Start Date | 2023-01-10 |
| Primary Completion | 2036-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,884 participants in total. It began in 2023-01-10 with a primary completion date of 2036-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
ABBVIE INC.
STUDY DIRECTOR
AbbVie
Frequently Asked Questions
Who can join the NCT05158894 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05158894 currently recruiting?
Yes, NCT05158894 is actively recruiting participants. Contact the research team at empresspregnancyregistry@iqvia.com for enrollment information.
Where is the NCT05158894 trial being conducted?
This trial is being conducted at Durham, United States, Ottawa, Canada.
Who is sponsoring the NCT05158894 clinical trial?
NCT05158894 is sponsored by AbbVie. The principal investigator is ABBVIE INC. at AbbVie. The trial plans to enroll 1,884 participants.
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