Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine

NCT ID
NCT07223008
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Johns Hopkins University
Conditions
Chronic Migraine Headache, Migraine, Refractory Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: A Pilot Study of Safety and Feasibility of Bilateral Middle Meningeal Artery Embolization (bMMAE) in Patients With Refractory Chronic Migraine Headache: The MMAE-MIGRAINE Trial

Enrollment: 13 participants (Estimated).

What is being studied

  • Device: embolization of middle meningeal arteries

Who may be eligible

Ages
18 Years to 80 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion criteria: * Age 18\<x\<80 * Meets ICHD3 criteria for chronic migraine, (ICHD3, 1.3; with inclusion of ICHD3 1.1 and 1.2.1 only), with first migraine before age 50 (in concordance with previously published trials in migraine therapy36,39) . Patients must experience bilateral migraine symptoms. * 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 criteria: * 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.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

  • Maryland, United States: 1

Sample of listed locations

  • Johns Hopkins Medicine — Baltimore, Maryland, 21287, United States — Recruiting

Study details

Start date
April 24, 2026
Primary completion date
April 1, 2027
Completion date
April 1, 2028
First posted
October 31, 2025
Collaborators
Medtronic

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07223008
Registry last updated
September 3, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07223008 on ClinicalTrials.gov

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