Aimovig Pregnancy Exposure Registry

NCT06150781 | Recruiting FDA Drug

• 1 other identifier: 20180125
• Study Type: observational
• Target: 2,842
• Locations: 1 country
• Sites: 1

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

Keywords

Erenumab-Aooe; AIMOVIG®

Outcome Measures

Primary Outcomes (1)

• Number of Infants Experiencing Major Congenital Malformations

  Up to 52 Weeks

Secondary Outcomes (9)

• 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

Study Arms (3)

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

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 DRUG

Dose and treatment duration will be advised by the HCP

Also known as: Aimovig®

Erenumab-aooe-exposed

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

IQVIA Virtual Site

Durham, North Carolina, 27703, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Migraine Disorders

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 29, 2023
• Study Start: January 27, 2021
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

US (1)