Bilateral middle meningeal artery embolization for refractory chronic migraine
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
This study will try blocking both middle meningeal arteries with Onyx in adults who have refractory bilateral chronic migraine to see if it is safe and lowers headaches.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07223008 on ClinicalTrials.gov |
What this trial studies
This interventional study uses Onyx to perform bilateral embolization of the middle meningeal arteries in adults with refractory chronic bilateral migraine. The FDA has allowed Onyx to be used in this protocol, and Medtronic is providing the supplies. Participants will undergo the embolization procedure at Johns Hopkins, complete a daily headache diary, give blood samples, and attend clinic visits over about eight months including six months of follow-up. The primary focus is on safety and feasibility while tracking headache frequency and severity alongside continued standard migraine treatments.
Who should consider this trial
Good fit: Adults aged approximately 18–79 with bilateral chronic migraine meeting ICHD-3 criteria, migraine onset before age 50, persistent symptoms for ≥12 months, and failure, intolerance, or inadequate response to at least two classes of preventive medications are ideal candidates.
Not a fit: Patients with unilateral migraine, those who are not treatment-refractory, people who require opiate or barbiturate rescue therapy for migraine, or those with contraindications to endovascular procedures are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the procedure could reduce headache frequency or severity and offer a new option for people with refractory bilateral chronic migraine.
How similar studies have performed: Embolization of the middle meningeal artery is an established technique for subdural hematoma, but its use for migraine is novel with only limited or preliminary clinical data for headache outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Risheng Xu, MD, PhD — Johns Hopkins School of Medicine
- Study coordinator: Kelly Szajna
- Email: ksajna1@jhmi.edu
- Phone: 000-000-0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.