Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Johns Hopkins University
- Study ID
- NCT07223008
- Status
- Recruiting
Conditions
- Chronic Migraine Headache
- Migraine
- Refractory Migraine
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- embolization of middle meningeal arteries — DEVICEParticipants will undergo embolization of the middle meningeal arteries with Onyx
Study Details
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.
Key Dates
- Start date
- Apr 24, 2026
- Status verified
- Apr 2026
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 13 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TreatmentParticipants will undergo embolization of the middle meningeal arteries with Onyx.
Primary Outcome Measure
Number of specified adverse events related to the study [ Time Frame: 30 days after procedure ]
Central Contacts
- Kelly Szajna000-000-0000
- Kallan Dirmeyer000-000-0000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Johns Hopkins Medicine | Baltimore | Maryland | 21287 | Risheng Xu, MD, PhD (PRINCIPAL_INVESTIGATOR) |
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