Assessing the effects of migraine treatments 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

This study is testing how safe and effective migraine treatments Ubrelvy and Qulipta are for pregnant women and their babies.

Quick facts

• Study type: Observational
• Enrollment: 1884 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: AbbVie (industry)
• Locations: 2 sites (Durham, North Carolina and 1 other locations)
• Trial ID: NCT05158894 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the outcomes for mothers and infants when pregnant women with migraines are treated with Ubrelvy (ubrogepant) or Qulipta (atogepant). It aims to enroll approximately 1,884 participants, including those exposed to either medication and a comparator group of unexposed women. The study will track fetal, maternal, and infant health outcomes for up to 12 months after birth. Participants will be monitored based on their treatment as prescribed by their healthcare providers.

Who should consider this trial

Good fit: Ideal candidates include pregnant women diagnosed with migraines who have been prescribed Ubrelvy or Qulipta.

Not a fit: Patients who are not pregnant or those who do not have a diagnosis of migraine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safety of migraine treatments during pregnancy, helping to inform clinical decisions.

How similar studies have performed: While there have been studies on migraine treatments, this specific observational approach focusing on pregnancy outcomes is relatively novel.

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

Where this trial is running

Durham, North Carolina and 1 other locations

• Iqvia /Id# 266904 — Durham, North Carolina, United States (RECRUITING)
• Ottawa Hospital Research Institute /ID# 280174 — Ottawa, Ontario, Canada (RECRUITING)

Study contacts

• Study coordinator: EMPRESS Pregnancy Call Center

Conditions: Migraine, Ubrelvy, Ubrogepant, Atogepant, Qulipta, MED-EPI-NEU-0649