Migraine DisordersMIGRAINENCT06735833
MMA Embolization for Refractory Chronic Migraine
A study testing Middle Meningeal Artery embolization in people with Migraine Disorders, run by Cerenovus, Part of DePuy Synthes Products, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Middle Meningeal Artery embolization
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Apr 2025to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Study Contact contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
University of Buffalo Medical Center
Buffalo, New York, 14203
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06032
- Recruiting
Semmes Murphey Foundation
Memphis, Tennessee, 38120
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
- Recruiting
Mount Sinai
New York, New York, 10029
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
- Recruiting
John Muir Physician Network Clin. Research Center
Walnut Creek, California, 94598
About this study
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
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.
- Conditions
- Migraine Disorders
- Being tested
- Middle Meningeal Artery embolization
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Meningeal Artery embolizationDevice
Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline, in number of migraine days
Measured: over 28 days post study intervention
Secondary outcomes (1)
Change from baseline in migraine days frequency
Measured: 3 months and 6 months post study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start23 Apr 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, multi-center, feasibility study in which up to 70 subjects will be consented to achieve a total of 30 subjects treated with TRUFILL n-BCA bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine in up to 10 US centers.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06735833
- Sponsor's protocol ID
- CNV202302
- Acronym
- MIGRAINE
- Status last verified
- Sep 2026
- First submitted
- 4 Dec 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson MedTech is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06735833
- Acronym / sponsor ID
- MIGRAINE / CNV202302
- Conditions
- Migraine Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- This is a prospective, multi-center, feasibility study in which up to 70 subjects will be consented to achieve a total of 30 subjects treated with TRUFILL n-BCA bilateral middle meningeal artery (MMA) embolization for the treatment of refractory chronic migraine in up to 10 US centers.
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle Meningeal Artery embolizationBilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system | Device | – |
Primary outcome
Change from baseline, in number of migraine days
Time frame: over 28 days post study intervention
1 secondary outcome
Change from baseline in migraine days frequency
Time frame: 3 months and 6 months post study intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson MedTech is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Contact contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle Meningeal Artery embolization in people with Migraine Disorders, run by Cerenovus, Part of DePuy Synthes Products, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (RA-MIGRAINECNV202302@ITS.JNJ.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline, in number of migraine days (time frame: over 28 days post study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.