RECRUITING

Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Ubrelvy and Qulipta Pregnancy Exposure Registry (EMPRESS): An Observational Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) and Qulipta (Atogepant) During Pregnancy

Quick Facts

Study Start:2023-01-10
Study Completion:2034-09-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05158894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Within the United States or Canada.
  2. * Qualify as a prospective enrollment, defined as currently pregnant.
  3. * A diagnosis of migraine by the patient's health care provider (HCP).
  4. * Provide contact information for the participant and her and her infant(s)', if applicable, HCPs.
  5. * Authorize their HCP(s) to release maternal and infant medical information to the registry, upon request.
  6. * Provide sufficient information to confirm eligibility for 1 of following:
  7. * 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.
  8. * 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.
  9. * 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.
  1. * Documentation of exposure to any gepants (acute or preventive) other than Ubrelvy and Qulipta, or CGRP monoclonal antibodies, from 5 half-lives of the respective treatment prior to conception or at any point during pregnancy before enrollment.
  2. * 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).
  3. * 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

Contacts and Locations

Study Contact

EMPRESS Pregnancy Call Center
CONTACT
+1-833-277-0206
empresspregnancyregistry@iqvia.com

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Iqvia /Id# 244683
Durham, North Carolina, 27703-8426
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-10
Study Completion Date2034-09-29

Study Record Updates

Study Start Date2023-01-10
Study Completion Date2034-09-29

Terms related to this study

Keywords Provided by Researchers

  • Migraine
  • Ubrelvy
  • Ubrogepant
  • Atogepant
  • Qulipta
  • MED-EPI-NEU-0649

Additional Relevant MeSH Terms

  • Migraine