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NCT05046613 Clinical Trial

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

Migraine Clinical Trial

— MONITOR  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05046613
Other study ID # BHV3000-402
Secondary ID C4951005
Status Recruiting
Phase
First received
Last updated
Start date November 3, 2021
Est. completion date April 30, 2034

Study information
Verified date May 2024
Source Pfizer
Contact Pfizer Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 780
Est. completion date April 30, 2034
Est. primary completion date April 30, 2034
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Rimegepant
75mg
• Not taking Rimegepant
No rimegepant

Locations
Country Name City State
United States PPD Morrisville North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Pfizer PPD, Part of Thermo Fisher Scientific

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major congenital malformation (birth defect) Healthcare provider report through the registry Annually beginning April 2022
Secondary Minor congenital malformation Healthcare provider report through the registry Annually beginning April 2022
Secondary Gestational hypertension Healthcare provider report through the registry Annually beginning April 2022
Secondary Pre-eclampsia Healthcare provider report through the registry Annually beginning April 2022
Secondary Eclampsia Healthcare provider report through the registry Annually beginning April 2022
Secondary Gestational diabetes Healthcare provider report through the registry Annually beginning April 2022
Secondary Spontaneous abortion Healthcare provider report through the registry Annually beginning April 2022
Secondary Stillbirth Healthcare provider report through the registry Annually beginning April 2022
Secondary Elective termination Healthcare provider report through the registry Annually beginning April 2022
Secondary Preterm birth Healthcare provider report through the registry Annually beginning April 2022
Secondary Small for gestational age Healthcare provider report through the registry Annually beginning April 2022
Secondary Postnatal growth deficiency Healthcare provider report through the registry Annually beginning April 2022
Secondary Infant developmental delay Healthcare provider report through the registry Annually beginning April 2022
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