Aimovig Pregnancy Exposure Registry

Recruiting

• Conditions: Migraine
• Interventions: Drug: erenumab-aooe

• Registration Number: NCT06150781
• Lead 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-27
• Study First Submitted: 2023-11-21
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Primary Completion: 2027-10-28
• Study Completion: 2027-10-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2842

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Erenumab-aooe-exposed	erenumab-aooe	Pregnant women with confirmed migraine who received erenumab-aooe before or during pregnancy will qualify to be included in the cohort. Dosing and treatment duration of erenumab-aooe as part of this observational study is at the discretion of the healthcare provider (HCP) in accordance with local clinical practice and local labeling.

Primary Outcome Measures

Name	Time	Method
Number of Infants Experiencing Major Congenital Malformations	Up to 52 Weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IQVIA Virtual Site; 🇺🇸 Durham, North Carolina, United States