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

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

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

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: Rimegepant; Other: Not taking Rimegepant

• Study Type: Observational
• Enrollment (Estimated): 780

Contacts and Locations

• Study Contact: Name: Pfizer Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • Evidera, a PPD business unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will include pregnant women of any age within the US with migraine who were treated with rimegepant as part of routine care at any time during pregnancy or just prior to pregnancy (up to 3 days prior to conception), as well as pregnant women with migraine not exposed to rimegepant before or during pregnancy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pregnant women with migraine exposed to 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)	Other: Rimegepant; 75mg
Pregnant women with migraine not exposed to 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	Other: Not taking Rimegepant; No rimegepant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major congenital malformation (birth defect)	Healthcare provider report through the registry	Annually beginning April 2022

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: PPD, Part of Thermo Fisher Scientific
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• Nurtec Pregnancy Registry
• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Estimated): November 4, 2029
• Study Completion (Estimated): April 30, 2034

Study Registration Dates

• First Submitted: September 8, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Migraine, Migraine Headache, Pregnant, Pregnancy, Infant
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; rimegepant sulfate
• Other Study ID Numbers: BHV3000-402; C4951005 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No