NCT06150781RecruitingAccepts Healthy Volunteers
Aimovig Pregnancy Exposure Registry
Amgen
Start Date
1/27/2021
Completion Date
10/28/2027
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 women with migraine unexposed to erenumeb-aooe.
Eligibility Criteria
Age Range: 18 years to 99 years
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.
Interventions
DRUG
erenumab-aooe
Conditions
Migraine
Locations
IQVIA Virtual Site
Durham, North Carolina 27703
United States