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 — DEVICE
    Participants 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: Treatment
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins MedicineBaltimoreMaryland21287
Kelly Szajna
000-000-0000
Risheng Xu, MD, PhD (PRINCIPAL_INVESTIGATOR)

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