Registry to assess pregnancy outcomes in women with migraines using Aimovig
GENESIS: AIMOVIG® Pregnancy Exposure Registry
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2842 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Amgen Industry-sponsored |
| Drugs / interventions | erenumab |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06150781 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older with a clinical diagnosis of migraine.
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.
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 performed: While this study focuses on a specific medication and population, similar observational studies have provided important safety data for other migraine treatments during pregnancy.
Eligibility criteria
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 this trial is running
Durham, North Carolina
- IQVIA Virtual Site — Durham, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.