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NCT Number: NCT06150781

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.

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Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

Female

Study type

Observational

Primary location

IQVIA Virtual Site

Durham, North Carolina, 27703, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

erenumab-aooe

Drug

Dose and treatment duration will be advised by the HCP

Other names: Aimovig®

Primary outcomes

  1. Number of Infants Experiencing Major Congenital Malformations

    Time frame: Up to 52 Weeks

Secondary outcomes

  1. Number of Women with Pregnancy Complications Following Erenumab-aooe Administration

    Time frame: Week 52

  2. Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth

    Time frame: Up to Approximately 38 Weeks

  3. Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age

    Time frame: Up to Approximately 38 Weeks

  4. Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations

    Time frame: Up to Week 52

  5. Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life

    Time frame: Up to Week 52

  6. Percentage of Participants with Maternal Outcomes

    Time frame: Up to Approximately 38 Weeks

    Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.

  7. Percentage of Participants with Fetal Outcomes

    Time frame: Up to Approximately 38 Weeks

    Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.

  8. Percentage of Participants with Infant Outcomes

    Time frame: Up to Week 52

    Infant outcomes: minor congenital malformations, size for gestational age, low birth weight, postnatal growth and development.

  9. 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)

    Time frame: Up to Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

GENESIS: AIMOVIG® Pregnancy Exposure Registry

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 29, 2023
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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