Aimovig Pregnancy Exposure Registry
AC
Overseen ByAmgen Call Center
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Amgen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Research Team
M
MD
Principal Investigator
Amgen
Eligibility Criteria
Inclusion Criteria
You are currently expecting a baby.
You cannot know the result of a pregnancy.
You have been diagnosed with migraine by a doctor.
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Treatment Details
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Women Without Migraine (External Comparator)Experimental Treatment0 Interventions
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.
Group II: Erenumab-aooe-unexposed (Internal Comparator)Experimental Treatment0 Interventions
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.
Group III: Erenumab-aooe-exposedExperimental Treatment1 Intervention
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.
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Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Trials
1,508
Recruited
1,433,000+
Founded
1980
Headquarters
Thousand Oaks, USA
Known For
Human Therapeutics
Top Products
Enbrel, Prolia, Neulasta, Otezla
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
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