MMA Embolization for Refractory Chronic Migraine
ConditionMigraine Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCerenovus, Part of DePuy Synthes Products, Inc.
About 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 does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Middle Meningeal Artery embolization
DeviceBilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change from baseline, in number of migraine days
Time frame
over 28 days post study interventionSecondary outcomes
1
Change from baseline in migraine days frequency
Time frame
3 months and 6 months post study interventionOther outcomes
1
Serious Adverse events
Time frame
At 4 weeks, 3 months, 6 months and 1 Year post study interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov