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Embolization Agent

MMA Embolization for Migraine (Migraine Trial)

N/A
Waitlist Available
Research Sponsored by Cerenovus, Part of DePuy Synthes Products, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is between 18 and 65 years of age at the time of consent
Age of onset of Chronic Migraine is less than or equal to 64 years
Must not have
Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.
Patients with a diagnosis of hemiplegic migraine or migrainous infarct
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using a liquid called TRUFILL n-BCA can safely and effectively treat chronic migraines by blocking the arteries in the head.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, embolization procedures can generally cause discomfort at the injection site, bleeding, infection risk, allergic reactions to materials used and sometimes unintended blockage of blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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My chronic migraines started when I was 64 or younger.
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I have been diagnosed with chronic migraine.
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I was diagnosed with migraine before turning 50.
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I have been diagnosed with migraines that don't respond to treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I regularly use opioids, cannabis, or medical marijuana.
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I have been diagnosed with hemiplegic migraine or migrainous infarct.
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I am not pregnant, breastfeeding, or able to become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Who is running the clinical trial?

Cerenovus, Part of DePuy Synthes Products, Inc.Lead Sponsor
9 Previous Clinical Trials
5,539 Total Patients Enrolled
~33 spots leftby Dec 2028
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