Aimovig Pregnancy Exposure Registry

Amgen

Status: Enrolling

Conditions: Migraine

Treatments: Drug: erenumab-aooe

Study type: Observational

Funder types: Industry

Identifiers

NCT06150781

20180125

Details and patient eligibility

About

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.

Enrollment: 2,842 estimated patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,842 participants in 3 patient groups

Erenumab-aooe-exposed

Description:

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.

Treatment:

Drug: erenumab-aooe

Erenumab-aooe-unexposed (Internal Comparator)

Description:

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)

Description:

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.