Aimovig Pregnancy Exposure Registry
Recruiting · NCT06150781 · Observational (researchers observe without assigning treatment) · Lead sponsor: Amgen
View the official record on ClinicalTrials.gov →Interventions studied
erenumab-aooe
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- IQVIA Virtual Site - Durham, North Carolina, United States