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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Study 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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Infants Experiencing Major Congenital Malformations
Secondary outcome measures
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)
Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth
Number of Women with Pregnancy Complications Following Erenumab-aooe Administration
+6 moreSide effects data
From 2023 Phase 4 trial • 701 Patients • NCT0408431435%
COVID-19
19%
Nasopharyngitis
15%
Constipation
9%
Fatigue
7%
Hypertension
6%
Depression
6%
Back pain
6%
Immunisation reaction
6%
Headache
6%
Migraine
5%
Nausea
5%
Arthralgia
4%
Vertigo
4%
Alopecia
4%
Pain in extremity
3%
Tonsillitis
3%
Cystitis
3%
Urinary tract infection
3%
Oropharyngeal pain
3%
Dizziness
3%
Chills
3%
Pruritus
3%
Pyrexia
3%
Cough
2%
Diarrhoea
2%
Post vaccination fever
2%
Abdominal pain upper
2%
Muscle spasms
2%
Osteoarthritis
2%
Procedural pain
1%
Appendicitis
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erenumab
Trial Design
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?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,374,846 Total Patients Enrolled
18 Trials studying Migraine
6,587 Patients Enrolled for Migraine
MDStudy DirectorAmgen
913 Previous Clinical Trials
921,289 Total Patients Enrolled
18 Trials studying Migraine
6,587 Patients Enrolled for Migraine
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