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Bilateral Embolization of the Middle Meningeal Arteries 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be in the study for about 8 months after enrolling, including 6 months of follow up after the procedure."
  • "Participants will also have several clinic visits and be asked to provide blood samples for research."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether using Onyx to plug two arteries near the brain is safe and possible for people with long-term migraines that have not improved with treatment. Onyx is not approved for treating migraines, but the FDA allows its use in this study. The study lasts about 8 months and includes a daily headache diary, clinic visits, and blood samples.

This study is to test the safety and feasibility of a procedure called embolization of the middle meningeal arteries (MMA), using a product called Onyx. Embolization creates a plug in the arteries. MMA embolization with Onyx is not approved for use in patients with migraines, but is currently used in patients with subdural hematomas. The FDA is allowing the use of Onyx in this study. It is thought that by using Onyx to block the middle meningeal arteries, the amount of migraine-causing substances which are released into the brain's bloodstream will be reduced. The company that manufactures Onyx, Medtronic, is providing the supplies for this study. Participants will be in the study for about 8 months after enrolling, including 6 months of follow up after the procedure. The participants will be asked to complete a daily headache diary and continue the participant's regular migraine medications. Participants will also have several clinic visits and be asked to provide blood samples for research.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and younger than 80.
  • Have chronic migraines that meet the study’s rules, with symptoms on both sides. Your first migraine must have started before age 50.
  • Have tried at least 2 types of migraine prevention drugs that did not help enough or caused side effects you could not tolerate. Migraines must have lasted at least 12 months, including at least 6 months after those treatments failed.
  • Have not used opioids or barbiturates as quick-relief migraine drugs. Use for other reasons is allowed.
  • Have no other condition causing the headaches. An MRI/MRA scan within 3 years of screening must show no underlying cause.
  • Have at least 1 migraine-free day in the past month in your headache diary, and a MIDAS score of at least 21, meaning migraines severely affect daily life.
  • Be able to read and write English and sign the consent form yourself.
  • Be able to finish all study tasks and follow-up visits.

Who can't join

  • Past skull surgery or procedures on blood vessels in the head or neck, or past radiation treatment to the head.
  • Opioid or barbiturate use for chronic migraines in the past year.
  • An abnormal area inside the skull on MRI, or other headache types ruled out by the study, such as cluster headaches. You also cannot join if treatment has changed your chronic migraines to occasional migraines.
  • Serious liver problems or a creatinine blood test above 2.0 mg/dL, which can signal kidney problems. People on dialysis may still qualify.
  • A history of cancer affecting the body or diseases where the immune system attacks the body, such as multiple sclerosis or rheumatoid arthritis.
  • A past life-threatening allergy to scan contrast dye, unless it can be managed with medical treatment.
  • Taking part in another migraine study that could affect this study’s results, including testing a migraine drug or procedure.
  • Other health or social concerns that the lead study doctor thinks could make the study unsafe, affect results, or prevent you from finishing.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

MD