Aimovig Pregnancy Exposure Registry

Last updated: October 2, 2024
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Headaches

Pain (Pediatric)

Treatment

erenumab-aooe

Clinical Study ID

NCT06150781
20180125
  • Ages 18-99
  • Female
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

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

Exclusion Criteria:

  • Women currently participating in another investigational device or investigationaldrug study, currently taking an investigational medicinal product, or having takenan investigational product within 3 months prior to last menstrual period (LMP) orduring pregnancy. Other investigational procedures while participating in this studyare 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 5half-lives prior to LMP through the end of pregnancy.

Study Design

Total Participants: 2842
Treatment Group(s): 1
Primary Treatment: erenumab-aooe
Phase:
Study Start date:
January 27, 2021
Estimated Completion Date:
October 28, 2027

Connect with a study center

  • IQVIA Virtual Site

    Durham, North Carolina 27703
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.