MMA Embolization for Refractory Chronic Migraine

NCT06735833 | Recruiting DMC FDA Device

• 1 other identifier: CNV202302
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Change from baseline, in number of migraine days

  over 28 days

Secondary Outcomes (1)

• Change from baseline in migraine days frequency

  3 months and 6 months

Other Outcomes (1)

• Serious Adverse events

  At 4 weeks, 3 months, 6 months and 1 Year

Interventions

Middle Meningeal Artery embolization DEVICE

Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.: lead

Study Sites (9)

Barrow Neurological Institute at St. Joseph's Hospital

Phoenix, Arizona, 85013, United States

NOT YET RECRUITING

John Muir Physician Network Clin. Research Center

Walnut Creek, California, 94598, United States

NOT YET RECRUITING

Hartford Hospital

Hartford, Connecticut, 06032, United States

NOT YET RECRUITING

University of Buffalo Medical Center

Buffalo, New York, 14203, United States

NOT YET RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Semmes Murphey Foundation

Memphis, Tennessee, 38120, United States

RECRUITING

West Virginia University

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Study Contact

CONTACT

RA-MIGRAINECNV202302@ITS.JNJ.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, multi-center, feasibility study in which up to 50 subjects will be consented to achieve a total of 30 subjects treated with TRUFILL n-BCA bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine in up to 5 US centers.

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 16, 2024
• Study Start: April 23, 2025
• Primary Completion (Estimated): December 25, 2028
• Study Completion (Estimated): May 15, 2029
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (9)