Clinical trial NCT06735833: MMA Embolization for Refractory Chronic Migraine
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, multi-center, feasibility study in which up to 50 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 5 US centers.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.


Eligibility criteria: Participant Inclusion Criteria, Candidates for this study must meet ALL the following inclusion criteria:

1. Patient is between 18 and 65 years of age (inclusive) at the time of consent.
2. Age of onset of Chronic Migraine ≤ 64 years.
3. Age of onset of migraine diagnosis \< 50 years.
4. Patient has a current diagnosis of refractory migraine.
5. Patient has a current diagnosis of Chronic migraine.

Participant Exclusion Criteria, Candidates will be excluded from participation if ANY of the following apply:

1. Patients with a history for the last 2 years of other types of headache. 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct. 5. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc.

6. Women who are pregnant, lactating, or who are of childbearing age. 7. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required.

Primary outcomes:
measure: Change from baseline, in number of migraine days
timeFrame: over 28 days
Secondary outcomes:
measure: Change from baseline in migraine days frequency
timeFrame: 3 months and 6 months
Other outcomes:
measure: Serious Adverse events
timeFrame: At 4 weeks, 3 months, 6 months and 1 Year
Locations:
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Semmes Murphey Foundation
state: Tennessee
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References: