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

Study Identifier
MED-EPI-NEU-0649
CT.gov Identifier
NCT05158894
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Migraine - General
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female
    Age
    18+ years
    Inclusion and Exclusion 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).

    Protocol 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.

    Study Locations

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