NCT05158894Recruiting
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
The Ubrelvy and Qulipta Pregnancy Exposure Registry EMPRESS: An Observational, Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) and Qulipta (Atogepant) During Pregnancy
Source: ClinicalTrials.gov · Last updated 15 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1884 (estimated)
- First submitted
- 2 Dec 2021
- Start date
- 10 Jan 2023
- Primary completion date
- Jan 2036
- Lead sponsor
- AbbVie
- Diseases
- Migraine
- NCT number
- NCT05158894
What you commit to
- Study type: Observational
- Planned participants: 1884
- From 10 Jan 2023 to the primary completion date, Jan 2036
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ottawa Hospital Research Institute /ID# 280174 Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Iqvia /Id# 266904 Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.