MMA Embolization for Refractory Chronic Migraine (Migraine)

May 7, 2026 updated by: Cerenovus, Part of DePuy Synthes Products, Inc.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Not yet recruiting
        • Barrow Neurological Institute at St. Joseph's Hospital
    • California
      • Walnut Creek, California, United States, 94598
        • Not yet recruiting
        • John Muir Physician Network Clin. Research Center
    • Connecticut
      • Hartford, Connecticut, United States, 06032
    • New York
    • Pennsylvania
    • Tennessee
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline, in number of migraine days
Time Frame: over 28 days
over 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in migraine days frequency
Time Frame: 3 months and 6 months
3 months and 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Serious Adverse events
Time Frame: At 4 weeks, 3 months, 6 months and 1 Year
At 4 weeks, 3 months, 6 months and 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2025

Primary Completion (Estimated)

December 25, 2028

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 11, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNV202302 (Other Identifier: Sponsor)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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