MMA Embolization for Refractory Chronic Migraine

Last updated: April 28, 2025
Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Pain

Oral Facial Pain

Treatment

Middle Meningeal Artery embolization

Clinical Study ID

NCT06735833
CNV202302
CNV202302
  • Ages 18-65
  • All Genders

Study 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

Inclusion

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.

  2. 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.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Middle Meningeal Artery embolization
Phase:
Study Start date:
April 28, 2025
Estimated Completion Date:
December 29, 2028

Connect with a study center

  • Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Semmes Murphey Foundation

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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