RecruitingNCT05046613

Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant

A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)

Sponsor

Pfizer

Enrollment

780 participants

Start Date

Sep 23, 2021

Study Type

OBSERVATIONAL

Conditions

Migraine

Summary

The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.

Eligibility

Sex: FEMALEMin Age: 0 Years

Inclusion Criteria2

Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy

Exclusion Criteria1

Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy

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