Aimovig Pregnancy Exposure Registry

Amgen2,842 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

2,842

Conditions

Migraine

Interventions

erenumab-aooeDRUG

Dose and treatment duration will be advised by the HCP

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

IQVIA Virtual Site

Durham, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Number of Infants Experiencing Major Congenital Malformations

Time frame: Up to 52 Weeks

Secondary Outcomes

Number of Women with Pregnancy Complications Following Erenumab-aooe Administration

Time frame: Week 52

Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth

Time frame: Up to Approximately 38 Weeks

Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age

Time frame: Up to Approximately 38 Weeks

Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations

Time frame: Up to Week 52

Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life

Time frame: Up to Week 52

Percentage of Participants with Maternal Outcomes

Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.

Time frame: Up to Approximately 38 Weeks

Percentage of Participants with Fetal Outcomes

Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.

Time frame: Up to Approximately 38 Weeks

Percentage of Participants with Infant Outcomes

Infant outcomes: minor congenital malformations, size for gestational age, low birth weight, postnatal growth and development.

Central Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.