MMA Embolization for Refractory Chronic Migraine
Recruiting · NCT06735833 · Interventional (participants receive a specific treatment) · Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Middle Meningeal Artery embolization
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- , Candidates for this study must meet ALL the following inclusion criteria:
- 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
- Participant
Exclusion criteria
- , Candidates will be excluded from participation if ANY of the following apply:
- Patients with a history for the last 2 years of other primary headache types, or secondary headache types except medication overuse headache
- Patients with diagnosis of hemiplegic migraine or migrainous infarct
- Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc
- Women who are pregnant, lactating, or who are of childbearing age
- 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
Where it is running
7 locations listed across 6 US states.
- John Muir Physician Network Clin. Research Center - Walnut Creek, California, United States
- Hartford Hospital - Hartford, Connecticut, United States
- Mount Sinai - New York, New York, United States
- Stony Brook University Medical Center - Stony Brook, New York, United States
- Thomas Jefferson University Hospital - Philadelphia, Pennsylvania, United States
- Semmes Murphey Foundation - Memphis, Tennessee, United States
- West Virginia University - Morgantown, West Virginia, United States