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Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine

NCT07223008 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-05-04

No results posted yet for this study

Summary

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

  • Migraine
  • Chronic Migraine Headache
  • Refractory Migraine

Interventions

DEVICE

embolization of middle meningeal arteries

Participants will undergo embolization of the middle meningeal arteries with Onyx

Sponsors & Collaborators

Principal Investigators

  • Risheng Xu, MD, PhD · Johns Hopkins School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-24
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223008 on ClinicalTrials.gov