Actively Recruiting
Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine
Led by Johns Hopkins University · Updated on 2026-05-04
13
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Meets criteria for chronic migraine with bilateral symptoms and first migraine before age 50
- Refractory chronic migraine defined by failure or intolerance to at least two classes of migraine preventatives
- No use of opiates or barbiturates as rescue therapy for migraine headaches
- No secondary headache disorders causing symptoms as shown by MRI/MRA within 3 years
- At least one migraine-free day in the last month
- Minimum MIDAS score of 21 indicating severe migraine disability
- Able to read and write in English
- Able to sign informed consent and complete study follow-up requirements
You will not qualify if you...
- History of cranial or cervical vascular interventions or surgery
- Use of opiates or barbiturates for chronic migraine treatment within one year
- Presence of intracranial lesions on routine MRI
- History of cranial radiation treatment
- Diagnoses of other headache types like hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache
- Significant liver impairment or serum creatinine over 2.0 mg/dL (dialysis patients may be eligible)
- History of systemic cancer or autoimmune inflammatory disorders
- Life-threatening allergy to radiographic contrast unless medically managed
- Participation in other migraine studies with interventions or experimental drugs
- Medical or social issues that may risk safety or interfere with study completion
- Patients with episodic migraine due to effective therapy after prior chronic migraine diagnosis
- Additional ineligible headache diagnoses as per ICHD3 criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
K
Kelly Szajna
CONTACT
K
Kallan Dirmeyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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