MMA Embolization for Refractory Chronic Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Middle Meningeal Artery embolization.
- Who it may be relevant to
- Registry conditions: Migraine Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device Middle Meningeal Artery embolization
Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
Primary outcome measures
- Change from baseline, in number of migraine days [Time frame: over 28 days post study intervention]
Secondary outcome measures (1)
- Change from baseline in migraine days frequency [Time frame: 3 months and 6 months post study intervention]
Eligibility criteria
Participant 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 9 centers
- Barrow Neurological Institute at St. Joseph's Hospital — Phoenix
- John Muir Physician Network Clin. Research Center — Walnut Creek
- Hartford Hospital — Hartford
- University of Buffalo Medical Center — Buffalo
- Mount Sinai — New York
- Stony Brook University Medical Center — Stony Brook
- Thomas Jefferson University Hospital — Philadelphia
- Semmes Murphey Foundation — Memphis
- … and 1 more center
Identifiers
NCT: NCT06735833 · CNV202302