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Recruiting NCT05046613

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

— Observational Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rimegepant, Not taking Rimegepant.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: from 0 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

Interventions

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

Primary outcome measures

  • Major congenital malformation (birth defect) [Time frame: Annually beginning April 2022]
Secondary outcome measures (12)
  • Minor congenital malformation [Time frame: Annually beginning April 2022]
  • Gestational hypertension [Time frame: Annually beginning April 2022]
  • Pre-eclampsia [Time frame: Annually beginning April 2022]
  • Eclampsia [Time frame: Annually beginning April 2022]
  • Gestational diabetes [Time frame: Annually beginning April 2022]
  • Spontaneous abortion [Time frame: Annually beginning April 2022]
  • Stillbirth [Time frame: Annually beginning April 2022]
  • Elective termination [Time frame: Annually beginning April 2022]
  • Preterm birth [Time frame: Annually beginning April 2022]
  • Small for gestational age [Time frame: Annually beginning April 2022]
  • Postnatal growth deficiency [Time frame: Annually beginning April 2022]
  • Infant developmental delay [Time frame: Annually beginning April 2022]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Evidera, a PPD business unit — Wilmington

Identifiers

NCT: NCT05046613 · BHV3000-402 · C4951005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗