Aimovig Pregnancy Exposure Registry

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Amgen
Study ID
NCT06150781
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • erenumab-aooe — DRUG
    Dose and treatment duration will be advised by the HCP

Study Details

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.

Key Dates

Start date
Jan 27, 2021
Status verified
Nov 2025
Primary completion
Oct 28, 2027
Completion
Oct 28, 2027

Study Design

Enrollment
2,842 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Number of Infants Experiencing Major Congenital Malformations [ Time Frame: Up to 52 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
IQVIA Virtual SiteDurhamNorth Carolina27703-

Find similar trials in Durham, NC

By condition
Migraine
By specialty
Neurology
By research site
IQVIA Virtual Site· Durham, NC

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