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

Trial Summary

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.

How does the treatment TRUFILL n-BCA liquid embolic system for migraines differ from other treatments?

The TRUFILL n-BCA liquid embolic system is unique because it involves embolization (blocking blood flow) of the middle meningeal artery, which is a novel approach for treating migraines. This method is different from typical migraine treatments like medications that target pain relief or blood flow changes, as it uses a liquid agent to physically alter blood vessel function. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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)

Treatment Details

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization Using Combined Particle Embolization and n-BCA with the Dextrose 5% in Water Push Technique for Chronic Subdural Hematomas: A Prospective Safety and Feasibility Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intra-arterial lidocaine therapy via the middle meningeal artery for migraine headache: Theory, current practice and future directions. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Middle Meningeal Artery Embolization with Liquid Embolic Agents for Chronic Subdural Hematoma: A Systematic Review and Meta-analysis. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Middle meningeal artery embolization reduces the post-operative recurrence rate of at-risk chronic subdural hematoma. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

[Effect of sumatriptan on cerebral blood flow during migraine headache: measurement by sequential SPECT used 99mTc-ECD background subtraction method]. [2016]