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NCT Number: NCT06735833

MMA Embolization for Refractory Chronic Migraine

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrow Neurological Institute at St. Joseph's Hospital, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • Patient has a current diagnosis of Chronic migraine

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

  • 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
  • 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

Treatment and study plan

Middle Meningeal Artery embolization

Device

Bilateral middle meningeal artery embolization using TRUFILL n-BCA liquid embolic system

Primary outcomes

  1. Change from baseline, in number of migraine days

    Time frame: over 28 days post study intervention

Secondary outcomes

  1. Change from baseline in migraine days frequency

    Time frame: 3 months and 6 months post study intervention

Other outcomes

  1. Serious Adverse events

    Time frame: At 4 weeks, 3 months, 6 months and 1 Year post study intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cerenovus, Part of DePuy Synthes Products, Inc.

Industry

Registry information

Official study 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

Acronym: MIGRAINE

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Dec 16, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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