Actively Recruiting
GENESIS: AIMOVIG Pregnancy Exposure Registry for Migraine in Pregnant Women
Led by Amgen · Updated on 2025-11-04
2842
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the occurrence of major birth defects in babies born to women with migraine who were exposed to erenumab-aooe during pregnancy compared to those not exposed. This observational study also includes pregnant women with migraine who were not exposed to this medication and pregnant women without migraine as comparison groups. The study aims to better understand possible risks of erenumab-aooe exposure during pregnancy using recognized birth defect classification methods. Pregnant women with confirmed migraine who took erenumab-aooe before or during pregnancy form one group, with treatment decisions made by their healthcare providers following local practices. Another group includes pregnant women with migraine who were not exposed to erenumab-aooe, serving as an internal comparison. A third group of pregnant women without migraine acts as an external comparison. Birth defects and other pregnancy outcomes will be tracked and classified using a standard system. Participants will be followed up to 52 weeks after birth to assess the number of infants with major congenital malformations as the main outcome. Additional outcomes include pregnancy complications, rates of miscarriage or preterm birth, infant growth and development issues, and various maternal and fetal health measures. Data will be collected through observation without intervention, with all outcomes monitored over the course of pregnancy and the infant's first year.
CONDITIONS
Brief Title
Aimovig Pregnancy Exposure Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Currently pregnant
- Outcome of the pregnancy must not be known
- Confirmed clinical diagnosis of migraine
You will not qualify if you...
- Participation in another investigational drug or device study or use of investigational products within 3 months before last menstrual period or during pregnancy
- Exposure to medications targeting the CGRP pathway from 5 half-lives prior to last menstrual period through the end of pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants who are pregnant women with or without migraine are observed for pregnancy outcomes and infant development through the first year of life.
Visits scheduled throughout pregnancy and up to 1 year postpartum
Trial Site Locations
Total: 1 location
1
IQVIA Virtual Site
Durham, North Carolina, United States, 27703
Actively Recruiting
Research Team
A
Amgen Call Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here