Embolization of the middle meningeal artery for chronic migraine relief

Feasibility Study to Evaluate the Initial Safety and Effectiveness of TRUFILL n-BCA Liquid Embolic System in Middle Meningeal Artery Embolization for the Preventive Treatment of Refractory Chronic Migraine

This study is testing a new procedure using a special liquid to block a specific artery in the head to see if it can help people with severe chronic migraines who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc. (Industry-sponsored)
• Locations: 9 sites (Phoenix, Arizona and 8 other locations)
• Trial ID: NCT06735833 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and effectiveness of using the TRUFILL n-BCA liquid embolic system to perform embolization of the bilateral middle meningeal artery in patients suffering from refractory chronic migraines. It is a prospective, multi-center feasibility study aimed at assessing how this intervention can alleviate symptoms in individuals who have not responded to conventional treatments. Participants will be closely monitored for outcomes related to migraine frequency and severity following the procedure.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with a diagnosis of refractory chronic migraine.

Not a fit: Patients with other types of headaches, hemiplegic migraines, or those currently using opioids or cannabis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant relief for patients suffering from chronic migraines that have not responded to other treatments.

How similar studies have performed: While this specific approach is novel, similar studies exploring embolization techniques for migraine relief have shown promising results.

Eligibility criteria

Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:

1. Patient is between 18 and 65 years of age (inclusive) at the time of consent.
2. Age of onset of Chronic Migraine ≤ 64 years.
3. Age of onset of migraine diagnosis \< 50 years.
4. Patient has a current diagnosis of refractory migraine.
5. Patient has a current diagnosis of Chronic migraine.

Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:

1\. Patients with a history for the last 2 years of other types of headache. 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.

6\. Women who are pregnant, lactating, or who are of childbearing age. 7. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required.

Where this trial is running

Phoenix, Arizona and 8 other locations

• Barrow Neurological Institute at St. Joseph's Hospital — Phoenix, Arizona, United States (Not_yet_recruiting)
• John Muir Physician Network Clin. Research Center — Walnut Creek, California, United States (Not_yet_recruiting)
• Hartford Hospital — Hartford, Connecticut, United States (Not_yet_recruiting)
• University of Buffalo Medical Center — Buffalo, New York, United States (Not_yet_recruiting)
• Mount Sinai — New York, New York, United States (Recruiting)
• Stony Brook University Medical Center — Stony Brook, New York, United States (Recruiting)
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
• Semmes Murphey Foundation — Memphis, Tennessee, United States (Recruiting)
• West Virginia University — Morgantown, West Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Migraine