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NCT06150781Recruiting

Aimovig Pregnancy Exposure Registry

GENESIS: AIMOVIG® Pregnancy Exposure Registry

Source: ClinicalTrials.gov · Last updated 4 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2842 (estimated)
First submitted
21 Nov 2023
Start date
Jan 2021
Primary completion date
Oct 2027
Lead sponsor
Amgen
Diseases
Migraine
NCT number
NCT06150781

What you commit to

  • Study type: Observational
  • Planned participants: 2842
  • From Jan 2021 to the primary completion date, Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to 99 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IQVIA Virtual Site
Coordinator of this site? Confirm its status
DurhamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.