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Clinical trial Recruiting at 1 site Observational Ages 18 to 99 Women only

Registry to assess pregnancy outcomes in women with migraines using Aimovig

Official title: GENESIS: AIMOVIG® Pregnancy Exposure Registry

Run by Amgen · NCT06150781 · Data updated 2026-11-12

This study is looking to see if using Aimovig during pregnancy affects the health of babies born to women with migraines compared to those who didn't use the medication.

More Migraine trials

Quick facts

Study typeObservational
Ages18 Years to 99 Years
SexWomen only
Enrollment2842 (estimated)
SponsorAmgen
Industry-sponsored
Drugs / interventionserenumab
Locations1 site (Durham, North Carolina)
StatusRecruiting
StartedJanuary 27, 2021
Main results expectedOctober 28, 2027
Study endsOctober 28, 2027
Registry record updatedNovember 4, 2025
Trial IDNCT06150781 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are pregnant women aged 18 and older with a clinical diagnosis of migraine.

Probably not a fit

Patients who are currently participating in other investigational studies or have been exposed to medications targeting the CGRP pathway may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to estimate the rate of major congenital malformations in infants born to women with migraines who were exposed to erenumab-aooe during pregnancy, compared to those who were not exposed. The study will involve pregnant women aged 18 and older who have a confirmed diagnosis of migraine and whose pregnancy outcomes are not yet known. Participants will be monitored to gather data on pregnancy outcomes and any potential effects of the medication on fetal development.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety of erenumab-aooe during pregnancy for women with migraines.

How similar studies have gone: While this study focuses on a specific medication and population, similar observational studies have provided important safety data for other migraine treatments during pregnancy.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age 18 years or older (at time of signing the informed consent)
* Currently pregnant
* The outcome of the pregnancy must not be known
* Confirmed clinical diagnosis of migraine

Exclusion Criteria:

* Women currently participating in another investigational device or investigational drug study, currently taking an investigational medicinal product, or having taken an investigational product within 3 months prior to last menstrual period (LMP) or during pregnancy. Other investigational procedures while participating in this study are excluded.
* Women exposed to any medications that target the calcitonin gene-related peptide (CGRP) pathway (ie, CGRP monoclonal antibody \[mAb\] or gepants) in the period from 5 half-lives prior to LMP through the end of pregnancy.

Where it's running

  • IQVIA Virtual Site
    Durham, North Carolina, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.