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MMA Embolization for Refractory Chronic Migraine

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe and effective the TRUFILL n-BCA liquid system is for treating chronic migraines that have not responded to treatment. It uses the liquid to block the middle meningeal arteries, blood vessels on both sides of the head. The study is for adults ages 18 to 65.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 65 years old when you agree to join.
  • Your chronic migraines began at age 64 or younger.
  • You were first diagnosed with migraines before age 50.
  • You currently have refractory migraines, meaning they have not responded to treatment.
  • You currently have chronic migraines, meaning frequent, ongoing migraines.

Who can't join

  • You have had other types of headaches in the past 2 years, except headaches caused by using headache medicine too often.
  • You have hemiplegic migraine, which causes weakness on one side of the body, or have had a stroke linked to a migraine.
  • You currently use opioids, cannabis, medical marijuana, or similar substances regularly.
  • You are a woman who is pregnant, breastfeeding, or of childbearing age.
  • You are in another trial testing a drug, device, or other treatment that could affect this study’s results. Studies that only observe people may be allowed, but the sponsor must approve.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 primary headache types, or secondary headache types except medication overuse headache 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct 3. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc 4. Women who are pregnant, lactating, or who are of childbearing age 5. 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

Study sites (8)

CA

CT

NY

PA

TN

WV