Recruiting NCT06150781
Aimovig Pregnancy Exposure Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: erenumab-aooe.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 99 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
GENESIS: AIMOVIG® Pregnancy Exposure Registry
Overview
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
- Drug erenumab-aooe
Dose and treatment duration will be advised by the HCP
Primary outcome measures
- Number of Infants Experiencing Major Congenital Malformations [Time frame: Up to 52 Weeks]
Secondary outcome measures (9)
- Number of Women with Pregnancy Complications Following Erenumab-aooe Administration [Time frame: Week 52]
- Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth [Time frame: Up to Approximately 38 Weeks]
- Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age [Time frame: Up to Approximately 38 Weeks]
- Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations [Time frame: 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 [Time frame: Up to Week 52]
- Percentage of Participants with Maternal Outcomes [Time frame: Up to Approximately 38 Weeks]
- Percentage of Participants with Fetal Outcomes [Time frame: Up to Approximately 38 Weeks]
- Percentage of Participants with Infant Outcomes [Time frame: Up to Week 52]
- 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) [Time frame: Up to Week 52]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- IQVIA Virtual Site — Durham
Identifiers
NCT: NCT06150781 · 20180125