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NCT Number: NCT05046613

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

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

Recruiting

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

0 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Evidera, a PPD business unit

Wilmington, North Carolina, 28401, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rimegepant

Other

75mg

Not taking Rimegepant

Other

No rimegepant

Primary outcomes

  1. Major congenital malformation (birth defect)

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

Secondary outcomes

  1. Minor congenital malformation

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  2. Gestational hypertension

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  3. Pre-eclampsia

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  4. Eclampsia

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  5. Gestational diabetes

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  6. Spontaneous abortion

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  7. Stillbirth

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  8. Elective termination

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  9. Preterm birth

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  10. Small for gestational age

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  11. Postnatal growth deficiency

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

  12. Infant developmental delay

    Time frame: Annually beginning April 2022

    Healthcare provider report through the registry

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • PPD, Part of Thermo Fisher Scientific

Registry information

Official study 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)

Acronym: MONITOR

Important dates

Study start
2021
Primary completion
2029
Study completion
2034
First posted
Sep 16, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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