Aimovig Pregnancy Exposure Registry
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.
| Condition(s) | Migraine |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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. |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Amgen |
| Locations | Durham, North Carolina, United States |
| Start date | 2021-01-27 |
| NCT ID | NCT06150781 |
| Official listing | https://clinicaltrials.gov/study/NCT06150781 |