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NCT05158894 | Not yet recruiting | Migraine

Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) During Pregnancy
Sponsor:

AbbVie

Brief 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 during pregnancy, as well as in 2 Ubrelvy-unexposed comparison groups. Ubrelvy (ubrogepant) is an approved drug for the acute treatment of migraine in adults. Approximately 560 pregnant women with migraine exposed to Ubrelvy and 560 pregnant women with migraine without exposure to Ubrelvy will be enrolled in this study in the United States. Participants enrolled in the Ubrelvy-exposed group will receive Ubrelvy as prescribed by their physician. There may be higher treatment burden for participants in this trial compared to their standard of care.

Condition or disease

Migraine

Study Type : Observational
Estimated Enrollment : 1120 participants
Official Title: The Ubrelvy Pregnancy Exposure Registry: An Observational, Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) During Pregnancy
Actual Study Start Date : December 31, 2022
Estimated Primary Completion Date : September 29, 2034
Estimated Study Completion Date : September 29, 2034

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Within the United States.
  • 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: adequate information to conclude that at least 1 dose of Ubrelvy was taken during pregnancy, including date(s) of administration.
    • Unexposed women with migraine (treated or untreated): adequate information to conclude that she has never taken Ubrelvy or discontinued Ubrelvy at least 3 months prior the first day of last menstrual period (LMP).
    Exclusion Criteria
    • Documentation of exposure to any gepants (acute or preventive) other than Ubrelvy from 5 half-lives prior to the first day of LMP 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).
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) During Pregnancy

Location Details

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

How to Participate

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Locations

Not yet recruiting

United States, North Carolina

Iqvia /Id# 244683

Durham, North Carolina, United States, 27703-8426