NCT05046613Recruiting
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
Pfizer
Start Date
9/23/2021
Completion Date
4/30/2034
Summary
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
Eligibility Criteria
Age Range: No minimum to No maximum
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
OTHER
Not taking Rimegepant
Conditions
Migraine
Locations
Evidera, a PPD business unit
Wilmington, North Carolina 28401
United States