MigraineNCT06150781
Aimovig Pregnancy Exposure Registry
An observational study of Migraine, run by Amgen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- erenumab-aooe
- How many people
- 2,842 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to 28 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IQVIA Virtual Site
Durham, North Carolina, 27703
About this study
Official title: GENESIS: 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.
- Conditions
- Migraine
- Being tested
- erenumab-aooe
- Keywords
- Erenumab-Aooe, AIMOVIG®
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erenumab-aooeDrug
Also called Aimovig®
Dose and treatment duration will be advised by the HCP
| Study group | Role | What they receive |
|---|---|---|
| Erenumab-aooe-exposed | 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. Receives: Drug: erenumab-aooe | |
| Erenumab-aooe-unexposed (Internal Comparator) | 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. | |
| Women Without Migraine (External Comparator) | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Infants Experiencing Major Congenital Malformations
Measured: Up to 52 Weeks
Secondary outcomes (9)
Number of Women with Pregnancy Complications Following Erenumab-aooe Administration
Measured: Week 52
Number of Women Experiencing Spontaneous Abortion, Still Birth, Elective Termination, and Preterm Birth
Measured: Up to Approximately 38 Weeks
Percentage of Infants of Women Exposed to Erenumab-aooe who are Small-for-gestational age
Measured: Up to Approximately 38 Weeks
Percentage of Infants of Women Exposed to Erenumab-aooe Experiencing Minor Congenital Malformations
Measured: 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
Measured: Up to Week 52
Percentage of Participants with Maternal Outcomes
Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.
Measured: Up to Approximately 38 Weeks
Percentage of Participants with Fetal Outcomes
Pregnancy outcomes: elective or spontaneous termination, fetal death, preterm birth.
Measured: Up to Approximately 38 Weeks
Percentage of Participants with Infant Outcomes
Infant outcomes: minor congenital malformations, size for gestational age, low birth weight, postnatal growth and development.
Measured: 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)
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start27 Jan 2021
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,842 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150781
- Sponsor's protocol ID
- 20180125
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2023
- Last updated
- 4 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GENESIS: AIMOVIG® Pregnancy Exposure Registry
- ClinicalTrials.gov ID
- NCT06150781
- Acronym / sponsor ID
- 20180125
- Conditions
- Migraine
- Keywords
- Erenumab-Aooe, AIMOVIG®
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,842 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Oct 2027 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Erenumab-aooe-exposed | – | Drug: erenumab-aooePregnant 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. |
| Erenumab-aooe-unexposed (Internal Comparator) | – | –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. |
| Women Without Migraine (External Comparator) | – | –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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erenumab-aooeAlso: Aimovig®Dose and treatment duration will be advised by the HCP | Drug | Erenumab-aooe-exposed |
Primary outcome
Number of Infants Experiencing Major Congenital Malformations
Time frame: Up to 52 Weeks
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Amgen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Infants Experiencing Major Congenital Malformations (time frame: Up to 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.