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

Pfizer

Summary

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

Eligibility

Age range: 0+ years
Sex: Female
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * 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 Criteria: • 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

Interventions

Other
Rimegepant
75mg
Other
Not taking Rimegepant
No rimegepant

Location

Evidera, a PPD business unit
Wilmington, North Carolina