GENESIS: AIMOVIG® Pregnancy Exposure Registry

Amgen1 site in 1 country2,842 target enrollmentJanuary 27, 2021

ConditionsMigraine

Interventionserenumab-aooe

Drugserenumab-aooe

Overview

Phase: Not Applicable
Intervention: erenumab-aooe
Conditions: Migraine
Sponsor: Amgen
Enrollment: 2842
Locations: 1
Primary Endpoint: Number of Infants Experiencing Major Congenital Malformations
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 27, 2021

End Date

October 28, 2027

Last Updated

5 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Amgen

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

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.

Intervention: erenumab-aooe

Outcomes

Primary Outcomes

Number of Infants Experiencing Major Congenital Malformations

Time Frame: Up to 52 Weeks

Secondary Outcomes

Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth(Up to Approximately 38 Weeks)
Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations(Up to Week 52)
Percentage of Participants with Maternal Outcomes(Up to Approximately 38 Weeks)
Number of Women with Pregnancy Complications Following Erenumab-aooe Administration(Week 52)
Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life(Up to Week 52)
Percentage of Participants with Fetal Outcomes(Up to Approximately 38 Weeks)
Percentage of Participants with Infant Outcomes(Up to Week 52)
Frequency of Major Congenital Malformations of Women with Migraine Exposed to Erenumab-aooe During Pregnancy with Women Representing the Prevalence of Birth Defects in the General Population (External Comparator)(Up to Week 52)
Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age(Up to Approximately 38 Weeks)