Clinical trial NCT06150781: Aimovig Pregnancy Exposure Registry
Official title: GENESIS: AIMOVIG® Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Erenumab-Aooe
AIMOVIG®
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-11-29
Enrollment: 2842
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

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.


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.

Primary outcomes:
measure: Number of Infants Experiencing Major Congenital Malformations
timeFrame: Up to 52 Weeks
Secondary outcomes:
measure: Number of Women with Pregnancy Complications Following Erenumab-aooe Administration
timeFrame: Week 52
measure: Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth
timeFrame: Up to Approximately 38 Weeks
measure: Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age
timeFrame: Up to Approximately 38 Weeks
measure: Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations
timeFrame: Up to Week 52
measure: Percentage of Infants of Women Exposed to Erenumab-aooe with Postnatal Growth and Development Deficiency Through the First Year of life
timeFrame: Up to Week 52
measure: Percentage of Participants with Maternal Outcomes
timeFrame: Up to Approximately 38 Weeks
measure: Percentage of Participants with Fetal Outcomes
timeFrame: Up to Approximately 38 Weeks
measure: Percentage of Participants with Infant Outcomes
timeFrame: Up to Week 52
measure: 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)
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Durham
country: United States
facility: IQVIA Virtual Site
state: North Carolina
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: