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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05046613
Acronym
MONITOR
Enrollment
780
Registered
2021-09-16
Start date
2021-09-23
Completion date
2034-04-30
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Migraine, Migraine Headache, Pregnant, Pregnancy, Infant

Brief summary

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

Interventions

OTHERRimegepant

75mg

OTHERNot taking Rimegepant

No rimegepant

Sponsors

Pfizer
Lead SponsorINDUSTRY
PPD, Part of Thermo Fisher Scientific
CollaboratorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
0 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major congenital malformation (birth defect)Annually beginning April 2022Healthcare provider report through the registry

Secondary

MeasureTime frameDescription
Minor congenital malformationAnnually beginning April 2022Healthcare provider report through the registry
Gestational hypertensionAnnually beginning April 2022Healthcare provider report through the registry
Pre-eclampsiaAnnually beginning April 2022Healthcare provider report through the registry
EclampsiaAnnually beginning April 2022Healthcare provider report through the registry
Gestational diabetesAnnually beginning April 2022Healthcare provider report through the registry
Spontaneous abortionAnnually beginning April 2022Healthcare provider report through the registry
StillbirthAnnually beginning April 2022Healthcare provider report through the registry
Elective terminationAnnually beginning April 2022Healthcare provider report through the registry
Preterm birthAnnually beginning April 2022Healthcare provider report through the registry
Small for gestational ageAnnually beginning April 2022Healthcare provider report through the registry
Postnatal growth deficiencyAnnually beginning April 2022Healthcare provider report through the registry
Infant developmental delayAnnually beginning April 2022Healthcare provider report through the registry

Countries

United States

Contacts

CONTACTPfizer Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026