Aimovig Pregnancy Exposure Registry

Migraine Clinical Trial

Official title:

GENESIS: AIMOVIG® Pregnancy Exposure Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150781
• Other study ID #: 20180125
• Status: Recruiting
• Start date: January 27, 2021
• Est. completion date: October 28, 2027

Study information

• Verified date: November 2023
• Source: Amgen
• Contact: Amgen Call Center
• Phone: 866-572-6436
• Email: medinfo[@]amgen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2842
• Est. completion date: October 28, 2027
• Est. primary completion date: October 28, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• erenumab-aooe
Dose and treatment duration will be advised by the HCP

Locations

Country	Name	City	State
United States	IQVIA Virtual Site	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Infants Experiencing Major Congenital Malformations		Up to 52 Weeks
Secondary	Number of Women with Pregnancy Complications Following Erenumab-aooe Administration		Week 52
Secondary	Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth		Up to Approximately 38 Weeks
Secondary	Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age		Up to Approximately 38 Weeks
Secondary	Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations		Up to Week 52
Secondary	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
Secondary	Percentage of Participants with Maternal Outcomes	Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.	Up to Approximately 38 Weeks
Secondary	Percentage of Participants with Fetal Outcomes	Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.	Up to Approximately 38 Weeks
Secondary	Percentage of Participants with Infant Outcomes	Infant outcomes: minor congenital malformations, size for gestational age, low birth weight, postnatal growth and development.	Up to Week 52
Secondary	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)		Up to Week 52

External Links

•   AmgenTrials clinical trials website