Erenumab for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effects of a migraine treatment called erenumab-aooe (a monoclonal antibody) on pregnancy. Researchers aim to determine if using this treatment during pregnancy affects the likelihood of major birth defects in newborns. They will compare babies from three groups: those whose mothers took erenumab-aooe, those whose mothers have migraines but did not take the treatment, and those whose mothers do not have migraines. Pregnant women with migraines who have not recently taken other migraine-specific drugs might be suitable for this study.
As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment benefits more patients, providing valuable insights for future mothers.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but you cannot participate if you have taken investigational drugs recently or medications targeting the CGRP pathway during pregnancy.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that erenumab-aooe, a treatment for migraines, appears safe during pregnancy based on current information. One study found that using erenumab while pregnant did not harm the baby. Additionally, the study noted no increase in pregnancy loss or birth defects.
While these results are promising, erenumab is not typically prescribed to pregnant women because its effects during pregnancy remain under investigation. As with any medication, discussing potential risks and benefits with a healthcare provider is essential.12345Why are researchers excited about this trial?
Most treatments for migraines during pregnancy center around symptom management with medications like acetaminophen or certain beta-blockers, which can be limited in effectiveness and safety for pregnant women. Erenumab-aooe, the treatment under study, stands out because it specifically targets and blocks the calcitonin gene-related peptide (CGRP) receptor, which plays a significant role in migraine development. This mechanism differs from other treatments that don't directly address this pathway. Researchers are excited because this targeted approach has the potential to reduce migraine frequency and severity without the same safety concerns for pregnant women associated with some traditional medications.
What evidence suggests that erenumab-aooe is effective for preventing congenital malformations in infants of women with migraine?
This trial will compare pregnant women with migraines who have been exposed to erenumab-aooe (Aimovig) with those who have not, as well as with pregnant women without migraines as an external comparator. Studies have shown that erenumab-aooe effectively reduces the number of migraine days, with about 50% of patients experiencing a 75% reduction. Aimovig is approved for preventing migraines in adults who experience them at least four days a month. However, limited information exists on its effects during pregnancy. One case study found no harm to the child when the mother used erenumab during pregnancy, but more research is needed to confirm its safety for unborn babies.12678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observation
Pregnant women with migraine are observed for exposure to erenumab-aooe and pregnancy outcomes
Follow-up
Participants are monitored for infant outcomes including congenital malformations and postnatal growth
What Are the Treatments Tested in This Trial?
Interventions
- erenumab-aooe
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
NCT06150781 | Aimovig Pregnancy Exposure Registry
Pregnant women with clinically confirmed migraine who were not exposed to erenumab-aooe before or during pregnancy will be included in the internal comparator ...
The use of erenumab for migraine prophylaxis during ...
Conclusions: The use of erenumab during pregnancy in our patient resulted in no known harm to the child. This case is unique in that the mother ...
CENTER FOR DRUG EVALUATION AND RESEARCH
risk of adverse maternal, fetal, and infant outcomes resulting from the use of Aimovig. (erenumab) during pregnancy. Reference ID: 4264882 ...
Aimovig | European Medicines Agency (EMA)
Aimovig was shown to be effective at reducing the number of days patients have migraines. Only patients with migraines at least 4 days a month were included in ...
Pivotal and Long-Term Efficacy Data
~5 out of 10 Aimovig®-treated patients cut migraine days by at least 75% Consider open-label treatment phase study limitations when interpreting results. The ...
6.
mothertobaby.org
mothertobaby.org/baby-blog/examining-migraine-medications-during-pregnancy-doesnt-have-to-be-a-headache/Examining Migraine Medications during Pregnancy Doesn ...
There was no increase in pregnancy loss or pattern of birth defects seen in the cases with known outcome.
GENESIS: AIMOVIG® Pregnancy Exposure Registry (20180125)
The registry will identify and record pregnancy complications, major and minor congenital malformations, spontaneous abortions, still births ...
Pregnancy and migraine - Sitecore
It is not known at this time if Aimovig could harm your unborn baby. Currently, Aimovig is generally not being prescribed to expectant moms or women who plan to ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.