Embolization for Migraine
(MMAE-Migraine Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a procedure called embolization of the middle meningeal arteries using a product called Onyx, which might help reduce migraine symptoms. The process creates a plug in the arteries to decrease substances that cause migraines. Participants should have chronic migraines persisting for at least a year and not responding well to at least two types of preventative treatments. If migraines regularly disrupt daily life and haven't improved with typical medications, this trial might be suitable. Participants will continue their usual migraine medications, keep a headache diary, and attend clinic visits for about 8 months. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for migraines.
Do I have to stop taking my current medications for the trial?
No, you can continue taking your regular migraine medications during the trial.
What prior data suggests that this procedure is safe for migraine patients?
Research has shown that blocking the middle meningeal arteries (MMA) is generally safe for treating conditions like subdural hematomas. Studies have found that this procedure carries a low risk of complications. Specifically, one study noted that many patients experienced fewer headaches after MMA embolization, with over 80% reporting improved headache outcomes, and some achieving complete relief.
While the use of Onyx for MMA embolization in migraines remains under study, the FDA has approved its use in this study, indicating a level of safety. Onyx is frequently used in other medical treatments, which contributes to its safety reputation. Overall, the procedure appears well-tolerated and shows promise for those with severe headache issues.12345Why are researchers excited about this trial?
Unlike standard migraine treatments that often rely on medication to manage symptoms, embolization of the middle meningeal arteries offers a new approach by physically blocking blood flow in specific arteries linked to migraine pain. This technique uses Onyx, a special material, to create a blockage that can potentially reduce the frequency and intensity of migraines. Researchers are excited about this treatment because it directly targets the blood vessels involved in migraines, offering a potential alternative for those who do not respond well to traditional medications.
What evidence suggests that embolization of the middle meningeal arteries might be an effective treatment for migraines?
Research has shown that embolization of the middle meningeal arteries (MMA), a procedure participants in this trial will undergo, may help treat migraines. In previous studies, patients who underwent this procedure reported fewer and less intense migraines. For instance, one study found that 89% of patients experienced fewer headaches and less severe pain afterward. Another study observed that some patients did not experience migraine symptoms again for up to 18 years. While these findings are promising, more research is needed to confirm the safety and effectiveness of this treatment for migraines.12567
Who Is on the Research Team?
Risheng Xu, MD, PhD
Principal Investigator
Johns Hopkins School of Medicine
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with chronic migraines that haven't improved after trying at least two types of preventative medications. Participants must have a history of migraines starting before age 50, experience bilateral symptoms, and not use opiates or barbiturates. They need an MRI/MRA confirming no secondary headache disorder within the last three years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo embolization of the middle meningeal arteries with Onyx
Follow-up
Participants are monitored for safety and effectiveness after the embolization procedure
What Are the Treatments Tested in This Trial?
Interventions
- Embolization of Middle Meningeal Arteries
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Medtronic
Industry Sponsor
Geoff Martha
Medtronic
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Richard Kuntz
Medtronic
Chief Medical Officer since 2023
MD, MSc