Plain-English translation of NCT05046613 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Migraine research guide →This is a registry study that follows pregnant women with migraine who use or have recently used rimegepant, a migraine medication. The study compares outcomes in women exposed to this medication with outcomes in women with migraine who were not exposed to it. By tracking mothers and babies over time, researchers hope to understand whether the medication is safe to use during pregnancy and breastfeeding.
When someone with migraine becomes pregnant, they face a difficult choice: continue treatment to manage their migraines or avoid medication to protect the pregnancy. There isn't enough real-world information yet about whether this medication affects the health of babies during or after pregnancy, so this study aims to gather that important safety information.
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You will share information about your migraine diagnosis, any migraine medications you take (before and during pregnancy), and medical details about your pregnancy and baby's health during the first year of life. This is done through a registry, meaning you'll provide this information to the research team, and they will follow your pregnancy outcomes and your baby's health for approximately 12 months after birth. No special visits or procedures are required beyond what you would normally do for prenatal and postnatal care.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
United States
Sponsor
Pfizer
Collaborators
PPD, Part of Thermo Fisher Scientific
Enrollment target
~780 participants
Started
September 2021
Primary completion
November 2029
Age range
0 Years and older
Sex
Female only
Last updated on clinicaltrials.gov in May 2026.
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