Actively Recruiting
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
Led by AbbVie · Updated on 2025-12-15
1884
Participants Needed
2
Research Sites
677 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living in the United States or Canada
- Currently pregnant (prospective enrollment)
- Diagnosed with migraine by a healthcare provider
- Able to provide contact information for yourself and your infant's healthcare providers, if applicable
- Agree to allow your healthcare providers to release maternal and infant medical information to the study
- Provide documented proof of at least one dose of Ubrelvy taken during pregnancy or
- Provide documented proof of at least one dose of Qulipta taken during pregnancy or
- For the internal comparator group, have never taken Ubrelvy or Qulipta or stopped Ubrelvy at least 2 days or Qulipta at least 5 days before conception
You will not qualify if you...
- Exposure to any gepants other than Ubrelvy and Qulipta or CGRP monoclonal antibodies from 5 half-lives before conception or anytime during pregnancy before enrollment
- Not currently pregnant (retrospective cases where pregnancy has ended and outcome is known)
- Contact the investigator for any clarification about inclusion or exclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Iqvia /Id# 266904
Durham, North Carolina, United States, 27703-8426
Actively Recruiting
2
Ottawa Hospital Research Institute /ID# 280174
Ottawa, Ontario, Canada, K1Y 4E9
Actively Recruiting
Research Team
E
EMPRESS Pregnancy Call Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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