RECRUITING

Aimovig Pregnancy Exposure Registry

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

GENESIS: AIMOVIG® Pregnancy Exposure Registry

Quick Facts

Study Start:2021-01-27

Study Completion:2027-10-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06150781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Amgen Call Center

CONTACT

866-572-6436

medinfo@amgen.com

Principal Investigator

STUDY_DIRECTOR

Amgen

Study Locations (Sites)

IQVIA Virtual Site

Durham, North Carolina, 27703

United States

Collaborators and Investigators

Sponsor: Amgen

MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-27

Study Completion Date2027-10-28

Study Record Updates

Study Start Date2021-01-27

Study Completion Date2027-10-28

Terms related to this study

Keywords Provided by Researchers

Erenumab-Aooe
AIMOVIG®

Additional Relevant MeSH Terms

Migraine