GENESIS: AIMOVIG® Pregnancy Exposure Registry
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:
• 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
Locations
United States
North Carolina
IQVIA Virtual Site
RECRUITING
Durham
Contact Information
Primary
Amgen Call Center
medinfo@amgen.com
866-572-6436
Time Frame
Start Date: 2021-01-27
Estimated Completion Date: 2027-10-28
Participants
Target number of participants: 2842
Treatments
Erenumab-aooe-exposed
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.
Erenumab-aooe-unexposed (Internal Comparator)
Pregnant women with clinically confirmed migraine who were not exposed to erenumab-aooe before or during pregnancy will be included in the internal comparator cohort.
Women Without Migraine (External Comparator)
Pregnant woman without migraine will be included in this cohort as external comparator. The Metropolitan Atlanta Congenital Defects Program (MACDP) birth defects classification system will be used to characterize major and minor congenital malformations for this study.
Related Therapeutic Areas
Sponsors
Leads: Amgen