Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2842 participants
OBSERVATIONAL
2021-01-27
2027-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Dose and treatment duration will be advised by the HCP
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Interventions
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erenumab-aooe
Dose and treatment duration will be advised by the HCP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Currently pregnant
* The outcome of the pregnancy must not be known
* Confirmed clinical diagnosis of migraine
Exclusion Criteria
* 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.
18 Years
99 Years
FEMALE
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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IQVIA Virtual Site
Durham, North Carolina, United States
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20180125
Identifier Type: -
Identifier Source: org_study_id
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