MMA Embolization for Migraine

(Migraine Trial)

Recruiting at 4 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.

Must not be taking: Opioids, Cannabis

Disqualifiers: Other headaches, Hemiplegic migraine, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with chronic migraines unresponsive to standard therapies. It tests the safety and effectiveness of the TRUFILL n-BCA liquid embolic system, a medical glue used to block blood flow in specific brain arteries. The trial seeks participants diagnosed with chronic migraines that persist despite treatment. Those with other types of headaches or who regularly use substances like opioids or cannabis are not eligible. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for chronic migraines.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who regularly use opioids, cannabis, or medical marijuana.

What prior data suggests that the TRUFILL n-BCA liquid embolic system is safe for bilateral middle meningeal artery embolization?

Research has shown that the TRUFILL n-BCA liquid embolic system, tested for treating migraines, is generally considered safe. However, its long-term safety remains uncertain. Some studies have found that it can cause serious, even life-threatening, problems in certain situations. While it has been used safely in many cases, risks exist. Participants should consider these risks and consult their doctor before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for migraines focus on relieving symptoms or preventing attacks using medications like triptans, beta-blockers, and anti-seizure drugs. However, the TRUFILL n-BCA liquid embolic system offers a groundbreaking approach by targeting the root cause of migraines through a procedure called embolization. This system works by blocking abnormal blood vessels in the brain, which are thought to trigger migraine attacks. Researchers are excited about this treatment because it represents a potential long-term solution that doesn't rely on daily medication and addresses the problem at its source.

What evidence suggests that the TRUFILL n-BCA liquid embolic system is effective for treating refractory chronic migraine?

Research has shown that the TRUFILL n-BCA liquid embolic system might help with migraines by blocking blood flow in certain arteries. Studies have found that people who underwent this procedure did not experience a return of migraine symptoms for up to 18 years, suggesting the treatment could provide long-term relief. Although the long-term safety and effectiveness of TRUFILL n-BCA as an implant remain uncertain, early results appear promising for those with chronic migraines. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with a diagnosis of refractory chronic migraine that started before they turned 50. It's not suitable for those using opioids or cannabis, women who are pregnant or breastfeeding, people with certain types of migraines like hemiplegic migraine, or anyone in another clinical trial that could affect this study.

Inclusion Criteria

My chronic migraines started when I was 64 or younger.

I have been diagnosed with migraines that don't respond to treatment.

I have been diagnosed with chronic migraine.

Exclusion Criteria

I regularly use opioids, cannabis, or medical marijuana.

I have been diagnosed with hemiplegic migraine or migrainous infarct.

I am not pregnant, breastfeeding, or able to become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bilateral middle meningeal artery embolization using the TRUFILL n-BCA liquid embolic system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the embolization procedure

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• TRUFILL n-BCA liquid embolic system

Trial Overview The study is testing the safety and effectiveness of TRUFILL n-BCA liquid embolic system used in bilateral middle meningeal artery (MMA) embolization as a treatment for patients suffering from severe chronic migraines that haven't responded to other treatments.

Who Is Running the Clinical Trial?

Cerenovus, Part of DePuy Synthes Products, Inc.

Lead Sponsor

Trials

10

Recruited

5,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06735833

NCT06735833 | MMA Embolization for Refractory Chronic ... This is a prospective, multi-center, feasibility study to investigate safety and effectiveness of TRUFILL n-BCA liquid embolic system in bilateral middle ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656459/

Middle meningeal artery embolization in migraine The results showed no recurrence of migraine symptoms in these patients during a follow-up period ranging from 2 to 18 years, suggesting that ...

3. jnis.bmj.com jnis.bmj.com/content/neurintsurg/17/Suppl_2/A56.2.full.pdf

6.3 Embolization for migraine management Conclusion The MIGRAINE study will provide initial data on the safety and effectiveness of TRUFILL n-BCA for MMA embolization in patients ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P990040c.pdf

TRUFILLⓇ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic ... The safety and effectiveness of the TRUFILLR n-BCA Liquid Embolic System as a long-term implant has not been established. Performing therapeutic ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06735833?term=AREA%5BBasicSearch%5D(migraine)&rank=6

MMA Embolization for 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 ...

6. jnjmedtech.com jnjmedtech.com/en-US/product/trufill-n-bca-liquid-embolic-system

TRUFILL® n-BCA Liquid Embolic System - J&J MedTech TRUFILL™ n-BCA does not require the use of expensive detachable tip microcatheters or dual lumen balloon catheters.3; Good Safety Profile​

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P990040b.pdf

Artificial Embolization Device The safety and effectiveness of the TRUFILLRn-BCA Liquid Embolic System as a long-term implant has not been established. As recommended by the ...

8. fabio-komlos-eomk.squarespace.com fabio-komlos-eomk.squarespace.com/s/Trufill_nBCA_IFU.pdf

TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic ... The safety data set included 54 n-BCA and. 52 PVA patients. Two ... Serious, including fatal, consequences can result with the use of the TRUFILL ...

9. cms.gov cms.gov/medicare/coverage/investigational-device-exemption-ide-studies/approved/g230327-nct06735833

G230327-NCT06735833 Feasibility study to evaluate the initial safety and effectiveness of TRUFILL n-BCA liquid embolic system in middle meningeal artery embolization.