RECRUITING

MMA Embolization for Refractory Chronic Migraine

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-28
Study Completion:2028-12-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06735833

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patient is between 18 and 65 years of age (inclusive) at the time of consent.
  2. 2. Age of onset of Chronic Migraine ≤ 64 years.
  3. 3. Age of onset of migraine diagnosis \< 50 years.
  4. 4. Patient has a current diagnosis of refractory migraine.
  5. 5. Patient has a current diagnosis of Chronic migraine.
  6. 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.
  7. 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Study Contact
CONTACT
2165439491
RA-MIGRAINECNV202302@ITS.JNJ.com

Study Locations (Sites)

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

Collaborators and Investigators

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 Registration Dates

Study Start Date2025-04-28
Study Completion Date2028-12-29

Study Record Updates

Study Start Date2025-04-28
Study Completion Date2028-12-29

Terms related to this study

Additional Relevant MeSH Terms

  • Migraine