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Study of Middle Meningeal Artery Embolization for Chronic Migraine

This study is testing a procedure called embolization of the middle meningeal arteries (MMA) using a product called Onyx. This procedure involves creating a plug in these arteries. While Onyx is used for other conditions, it is not yet approved for migraines. Researchers believe blocking these arteries might reduce substances that cause migraines. This study aims to see if this procedure is safe and possible for people with chronic migraine. You might be able to join if you are 18 to 80 years old and have chronic migraine with symptoms on both sides of your head. The main goal is to track any side effects related to the procedure within 30 days. The study is currently unclear on its recruitment status and plans to enroll 13 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 13 participants to test the safety and feasibility of the procedure.
What's involved
You would be in the study for about 8 months after joining, which includes 6 months of follow-up after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after the procedure, with adverse events measured at 30 days.

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NCT07223008

Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine

Recruiting
NAAges 18–80InterventionalTreatment
Johns Hopkins University
~13 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:embolization of middle meningeal arteries

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of specified adverse events related to the study
Measured over 30 days after procedure

Conditions

Migraine
Chronic Migraine Headache
Refractory Migraine

Explore related trials

Migraine

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Risheng Xu, MD, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

Who to contact

Kelly Szajna
[email protected]
000-000-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18\<x\<80
Satisfy criteria for refractory chronic migraine defined as failure of, inadequate response to, or inability to tolerate migraine preventatives in at least 2 classes. Migraine preventatives include beta-blockers, calcium channel blockers, anti-convulsants (valproic acid, topiramate), anti-depressants (venlafaxine, amitriptyline), CGRP monoclonal antibodies, botulinum toxin injections. Chronic migraines must have persisted for at least 12 months prior to enrollment and at least 6 months after failing 2 classes of medication.
Has not used opiates or barbiturates as acute (rescue) therapy for migraine headache. Opiate or barbiturate use for reasons other than migraine is allowed. Other classes of acute migraine medications are acceptable. Acute (rescue, abortive) medications for migraines include acetaminophen, NSAIDs (ibuprofen, naproxen), gepants, triptans, anti-emetics (anti-nausea medications).
Exclusion of secondary headache disorder which may cause migraines/symptoms, including MRI/MRA (performed as routine care showing no underlying lesion that may be causing headaches, within 3 years of screening).
At least one migraine free day during the last month per headache diary.
Minimum MIDAS score of 21 (reflecting severely disabling migraine, in concordance with ongoing MMA lidocaine infusion trial44).
Able to read/write in English. Patients who are not English language users will not be enrolled as the study assessments are only validated in English.
Able to sign informed consent for themselves.
Able to complete study requirements/follow-up as outlined in study plan section 3.6.

Exclusion

History of cranial or cervical vascular interventions or surgery, including craniotomy/craniectomy, shunt placement, stereoelectroencephalography, and carotid endarterectomy.
A history of opiate or barbiturate use for the treatment of chronic migraine within one year.
Current intracranial lesions as determined by routine care MRI for exclusion of secondary headache disorders.
History of cranial radiation treatment.
Patients with additional diagnoses under ICHD3 (such as hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache) are ineligible
Significant liver function impairment or serum creatinine \> 2.0 mg/dL. Patients with elevated creatinine levels who are on dialysis may be eligible.
History of systemic malignancy or auto-immune inflammatory disorders (such as multiple sclerosis, rheumatoid arthritis, autoimmune diseases).
History of life-threatening allergy to radiographic contrast. Patients with this allergy may be eligible if it can be managed medically.
Enrollment in another migraine study which could confound this study's endpoints, including undergoing any intervention or receiving an experimental drug under investigation for migraine therapy.
Additional medical or social concerns which could confound this study's endpoints or otherwise create undue risk or interfere with the participant's ability to complete the study, as assessed by the PI.
As this study is open only to patients with chronic migraine, which is refractory to treatment, patients who have previously been diagnosed with chronic migraine but now experience episodic migraine due to effective therapy are not eligible.
Patients with additional diagnoses under ICHD3 (such as hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache) are ineligible.

What this trial measures

  • Number of specified adverse events related to the study30 days after procedure

    Strokes (ischemic and hemorrhagic), blindness, facial palsy, epidural hematoma, and death within 30 days of the embolization