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Recruiting NCT06150781

Aimovig Pregnancy Exposure Registry

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Trial Parameters

Condition Migraine
Sponsor Amgen
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,842
Sex FEMALE
Min Age 18 Years
Max Age 99 Years
Start Date 2021-01-27
Completion 2027-10-28
Interventions
erenumab-aooe

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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.

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.

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