RecruitingNot Applicable

MMA Embolization for Refractory Chronic Migraine

United States70 participantsStarted 2025-04-23

Plain-language summary

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 participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline, in number of migraine days

Timeframe: over 28 days post study intervention

Trial details

NCT IDNCT06735833

SponsorCerenovus, Part of DePuy Synthes Products, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-25

Contact for this trial

Study Contact

RA-MIGRAINECNV202302@ITS.JNJ.com

View on ClinicalTrials.gov More Migraine Disorders trials