Aimovig Pregnancy Exposure Registry

GENESIS: AIMOVIG® Pregnancy Exposure Registry

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 Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: erenumab-aooe

• Study Type: Observational
• Enrollment (Estimated): 2842

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Recruiting
      • IQVIA Virtual Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: erenumab-aooe; Dose and treatment duration will be advised by the HCP; Other Names: Aimovig®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Infants Experiencing Major Congenital Malformations	Up to 52 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Women with Pregnancy Complications Following Erenumab-aooe Administration		Week 52
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 who are Small-for-gestational age		Up to Approximately 38 Weeks
Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations		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		Up to Week 52
Percentage of Participants with Maternal Outcomes	Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.	Up to Approximately 38 Weeks
Percentage of Participants with Fetal Outcomes	Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.	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.	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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Erenumab-Aooe; AIMOVIG®
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; erenumab
• Other Study ID Numbers: 20180125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No