Migraine
Conditions
Keywords
Erenumab-Aooe, AIMOVIG®
Brief 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.
Interventions
DRUGerenumab-aooe
Dose and treatment duration will be advised by the HCP
Sponsors
Amgen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Women currently participating in another investigational device or investigational drug study, currently taking an investigational medicinal product, or having taken an investigational product within 3 months prior to last menstrual period (LMP) or during pregnancy. Other investigational procedures while participating in this study are excluded. * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Infants Experiencing Major Congenital Malformations | Up to 52 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth | Up to Approximately 38 Weeks | — |
| Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age | Up to Approximately 38 Weeks | — |
| Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations | Up to Week 52 | — |
| Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life | Up to Week 52 | — |
| Number of Women with Pregnancy Complications Following Erenumab-aooe Administration | Week 52 | — |
| Percentage of Participants with Fetal Outcomes | Up to Approximately 38 Weeks | Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth. |
| Percentage of Participants with Infant Outcomes | Up to Week 52 | Infant outcomes: minor congenital malformations, size for gestational age, low birth weight, postnatal growth and development. |
| 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) | Up to Week 52 | — |
| Percentage of Participants with Maternal Outcomes | Up to Approximately 38 Weeks | Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth. |
Countries
United States
Contacts
Primary ContactAmgen Call Center
Outcome results
None listed