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NCT06735833NARecruiting

MMA Embolization for Refractory Chronic Migraine

Cerenovus, Part of DePuy Synthes Products, Inc.

Start Date

4/23/2025

Completion Date

7/31/2029

Summary

This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine.

Eligibility Criteria

Age Range: 18 years to 65 years

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 primary headache types, or secondary headache types except medication overuse headache 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct 3. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc 4. Women who are pregnant, lactating, or who are of childbearing age 5. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Participants in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required

Interventions

DEVICE

Middle Meningeal Artery embolization

Interested in This Trial?

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Conditions

Migraine Disorders

Locations

Barrow Neurological Institute at St. Joseph's Hospital

Phoenix, Arizona 85013

United States

John Muir Physician Network Clin. Research Center

Walnut Creek, California 94598

United States

Hartford Hospital

Hartford, Connecticut 06032

United States

University of Buffalo Medical Center

Buffalo, New York 14203

United States

Mount Sinai

New York, New York 10029

United States

Stony Brook University Medical Center

Stony Brook, New York 11794

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Semmes Murphey Foundation

Memphis, Tennessee 38120

United States

West Virginia University

Morgantown, West Virginia 26506

United States