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

Recruiting

• Conditions: Migraine
• Interventions: Other: Rimegepant; Other: Not taking Rimegepant

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-16
• Study Start: 2021-11-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-21
• Primary Completion: 2034-04-30
• Study Completion: 2034-04-30

Recruitment & Eligibility

• Status: 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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with migraine exposed to Rimegepant	Rimegepant	Pregnant women with a diagnosis of migraine who are exposed to rimegepant at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception)
Pregnant women with migraine not exposed to Rimegepant	Not taking Rimegepant	Pregnant women with a diagnosis of migraine who are not exposed to rimegepant (up to 5 product half-lives prior to conception) but who may be exposed to other products for the treatment/prevention of migraine at any time during pregnancy or just prior to pregnancy

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
Stillbirth	Annually beginning April 2022	Healthcare provider report through the registry
Pre-eclampsia	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)

PPD; 🇺🇸 Morrisville, North Carolina, United States