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

NCT05158894 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1884

Last updated 2025-12-15

No results posted yet for this study

Summary

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

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2036-01-31
Completion
2036-01-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05158894 on ClinicalTrials.gov