Status:
RECRUITING
Aimovig Pregnancy Exposure Registry
Lead Sponsor:
Amgen
Conditions:
Migraine
Eligibility:
FEMALE
18-99 years
Brief Summary
The primary objective of this study is to estimate the proportion of major congenital malformations in infants of women with migraine exposed to erenumab-aooe during pregnancy compared to infants of w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 28 2027
Estimated Enrollment :
2842 Patients enrolled
Trial Details
Trial ID
NCT06150781
Start Date
January 27 2021
End Date
October 28 2027
Last Update
November 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IQVIA Virtual Site
Durham, North Carolina, United States, 27703