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

Active, not recruiting

• Conditions: Migraine

• Registration Number: NCT05046613
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-16
• Study Start: 2021-09-23
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-26
• Primary Completion: 2034-04-30
• Study Completion: 2034-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 780

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major congenital malformation (birth defect)	Annually beginning April 2022	Healthcare provider report through the registry

Secondary Outcome Measures

Name	Time	Method
Elective termination	Annually beginning April 2022	Healthcare provider report through the registry
Gestational hypertension	Annually beginning April 2022	Healthcare provider report through the registry
Spontaneous abortion	Annually beginning April 2022	Healthcare provider report through the registry
Postnatal growth deficiency	Annually beginning April 2022	Healthcare provider report through the registry
Pre-eclampsia	Annually beginning April 2022	Healthcare provider report through the registry
Stillbirth	Annually beginning April 2022	Healthcare provider report through the registry
Minor congenital malformation	Annually beginning April 2022	Healthcare provider report through the registry
Eclampsia	Annually beginning April 2022	Healthcare provider report through the registry
Gestational diabetes	Annually beginning April 2022	Healthcare provider report through the registry
Preterm birth	Annually beginning April 2022	Healthcare provider report through the registry
Small for gestational age	Annually beginning April 2022	Healthcare provider report through the registry
Infant developmental delay	Annually beginning April 2022	Healthcare provider report through the registry

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States