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NCT06150781 | RECRUITING | Migraine

Aimovig Pregnancy Exposure Registry
Sponsor:

Amgen

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.

Condition or disease

Migraine

Intervention/treatment

erenumab-aooe

Study Type : OBSERVATIONAL
Estimated Enrollment : 2842 participants
Official Title : GENESIS: AIMOVIG® Pregnancy Exposure Registry
Actual Study Start Date : 2021-01-27
Estimated Primary Completion Date : 2027-10-28
Estimated Study Completion Date : 2027-10-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: 1
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.
Aimovig Pregnancy Exposure Registry

Location Details

NCT06150781

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, North Carolina

IQVIA Virtual Site

Durham, North Carolina, United States, 27703