RECRUITING

Aimovig Pregnancy Exposure Registry

Description

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.

Conditions

Migraine
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Related Conditions:

Migraine

Study Overview

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Study Details

Study overview

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.

GENESIS: AIMOVIG® Pregnancy Exposure Registry

Aimovig Pregnancy Exposure Registry

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

Durham

IQVIA Virtual Site, Durham, North Carolina, United States, 27703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Amgen,

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

2027-10-28