Assessing the effects of migraine treatments during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: empresspregnancyregistry@iqvia.com
• Phone: 833-782-7241

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.