Observational Study of Rimegepant Exposure During Pregnancy

This is an observational study looking at the health of mothers, babies, and infants after exposure to a migraine medication called rimegepant. Researchers want to understand if taking rimegepant (75mg) during or just before pregnancy affects outcomes compared to not taking it. You may be able to join if you are a pregnant woman with migraine who has either taken rimegepant or has not. The main goal is to see if there are any major birth defects. This study is currently unclear on its recruitment status and plans to enroll 780 women.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatment. It aims to enroll 780 pregnant women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess major congenital malformations (birth defects) annually, starting April 2022, and fetal, maternal, and infant outcomes through 12 months of age.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05046613

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

Recruiting
Not specifiedAges 0+Observational
Pfizer
~780 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:RimegepantNot taking Rimegepant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major congenital malformation (birth defect)
Measured over Annually beginning April 2022
Migraine
1 sites across 1 states
North Carolina1
  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

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Eligibility criteria

Inclusion

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
  • Major congenital malformation (birth defect)Annually beginning April 2022

    Healthcare provider report through the registry