Migraine Disorders
Conditions
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.
Interventions
Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system
Sponsors
Cerenovus, Part of DePuy Synthes Products, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
This is a prospective, multi-center, feasibility study in which up to 70 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 10 US centers.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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 primary headache types, or secondary headache types except medication overuse headache 2. Patients with diagnosis of hemiplegic migraine or migrainous infarct 3. Patients with current regular use of Opioids, Cannabis, Medical Marijuana, etc 4. Women who are pregnant, lactating, or who are of childbearing age 5. Current involvement in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Participants in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Sponsor approval is required
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline, in number of migraine days | over 28 days post study intervention |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in migraine days frequency | 3 months and 6 months post study intervention |
Countries
United States
Contacts
CONTACTStudy Contact
Outcome results
None listed