Recruiting

Aimovig

Sponsor:

Amgen

Code:

NCT06150781

Conditions

Migraine

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

erenumab-aooe

Study Details

Brief 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.

Conditions

Migraine

Study ID

NCT06150781

Start date

Jan 27, 2021

Status verified date

Nov, 2025

Completion date

Oct 28, 2027

Anticipated

Primary completion date

Oct 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

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.

Study Design

Enrollment

2842 participants

Anticipated

Interventions and Outcome Measures

Arms

Erenumab-aooe-exposed

Pregnant women with confirmed migraine who received erenumab-aooe before or during pregnancy will qualify to be included in the cohort. Dosing and treatment duration of erenumab-aooe as part of this observational study is at the discretion of the healthcare provider (HCP) in accordance with local clinical practice and local labeling.

Erenumab-aooe-unexposed (Internal Comparator)

Pregnant women with clinically confirmed migraine who were not exposed to erenumab-aooe before or during pregnancy will be included in the internal comparator cohort.

Women Without Migraine (External Comparator)

Pregnant woman without migraine will be included in this cohort as external comparator. The Metropolitan Atlanta Congenital Defects Program (MACDP) birth defects classification system will be used to characterize major and minor congenital malformations for this study.

Interventions

erenumab-aooe

Dose and treatment duration will be advised by the HCP

Primary outcome measure

  • Number of Infants Experiencing Major Congenital Malformations [ Time Frame: Up to 52 Weeks ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

IQVIA Virtual Site

Recruiting

Durham, North Carolina, United States, 27703

More Information

Sponsor

Amgen

Last update posted

Nov 4, 2025

Last verified

Nov, 2025

Keywords

  • Erenumab-Aooe
  • AIMOVIG®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amgen on 2025-11-04.