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)
2 other identifiers
observational
780
1 country
1
Brief Summary
The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedStudy Start
First participant enrolled
September 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2034
May 5, 2026
May 1, 2026
8.1 years
September 8, 2021
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major congenital malformation (birth defect)
Healthcare provider report through the registry
Annually beginning April 2022
Secondary Outcomes (12)
Minor congenital malformation
Annually beginning April 2022
Gestational hypertension
Annually beginning April 2022
Pre-eclampsia
Annually beginning April 2022
Eclampsia
Annually beginning April 2022
Gestational diabetes
Annually beginning April 2022
- +7 more secondary outcomes
Study Arms (2)
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)
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
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- PPD, Part of Thermo Fisher Scientificcollaborator
Study Sites (1)
Evidera, a PPD business unit
Wilmington, North Carolina, 28401, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2021
First Posted
September 16, 2021
Study Start
September 23, 2021
Primary Completion (Estimated)
November 4, 2029
Study Completion (Estimated)
April 30, 2034
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share
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.