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Recruiting Observational

Aimovig Pregnancy Exposure Registry

NCT06150781 · tracked via the Priya Life Science USA tracker
Sponsor
Phase
Observational
Started
2021-01-27
Last updated
2025-11-04

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

erenumab-aooe

erenumab-aooe: Dose and treatment duration will be advised by the HCP

Study 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

Sex
FEMALE
Min age
18 Years
Max age
99 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Number of Infants Experiencing Major Congenital Malformations — Up to 52 Weeks

Trial sites (1)

FacilityCityRegionStatus
IQVIA Virtual Site Durham North Carolina Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06150781 on ClinicalTrials.gov ↗ ← All trials in the USA