Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine. (FAST-EM-2)

June 5, 2026 updated by: Zeguang Ren, The Affiliated Hospital Of Guizhou Medical University

Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine: A Multicenter, Prospective, Double-blind, Multigroup, Randomized Controlled Trial.

This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.This study will enroll 150 subjects with a long history of headache from multiple clinical centers, who will be randomly assigned using a stratified randomization method via computer and web-based software. Stratified randomization will be performed according to study centers (different sub-centers). Subjects will be randomly allocated in a 1:1:1 ratio to the unilateral embolization group, bilateral embolization group, or conventional pharmacotherapy group (hereinafter referred to as the "control group"), with 50 subjects in each group. The unilateral embolization group will receive unilateral MMA interventional embolization plus conventional pharmacotherapy, the bilateral embolization group will receive bilateral MMA interventional embolization plus conventional pharmacotherapy, and the control group will receive only conventional standard pharmacotherapy. Baseline data prior to randomization and data on primary and secondary endpoint scores will be collected for all enrolled subjects. Regular follow-up will be conducted to evaluate the recovery of headache.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Zeguang Ren, MD. PhD.
  • Phone Number: +86 0851-86770232.
  • Email: renzem@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18~80 years old (inclusive), regardless of gender.
  2. Voluntary written informed consent.
  3. Migraine diagnosed by neurologists/pain specialists according to the current International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria for migraine with or without aura.
  4. Migraine attack frequency of no less than 4 days per month within one month prior to enrollment.
  5. History of pharmacotherapy for migraine prophylaxis or treatment for at least 6 months.

Exclusion Criteria:

  1. Findings on cerebral angiography indicating secondary headache due to intracranial vascular disorders, including dural arteriovenous fistula, arteriovenous malformation, venous malformation, or other relevant cerebrovascular lesions; Moyamoya disease; or high-risk vascular anatomical variants unsuitable for safe vascular access or contraindicating MMA embolization.
  2. Complicated with cervical spondylosis and secondary headache of otogenic, rhinogenic, odontogenic origin; patients with a history of trigeminal autonomic cephalalgias; headache with other definite etiologies or secondary headache;
  3. Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions;
  4. Patients planning to undergo surgery within 90 days;
  5. Patients with a life expectancy of less than 12 months;
  6. Patients with a definite history of contrast media allergy;
  7. Patients with a history of opioid addiction;
  8. Breastfeeding or pregnant women, or patients with fertility plans within half a year;
  9. Subjects who participated in other clinical trials of drugs or medical devices before enrollment and did not reach the time limit of the primary study endpoint;
  10. Unable to understand headache-related assessment data such as headache diaries and requiring assistance from others to complete them;
  11. Patients with poor compliance judged by the investigator and unable to complete the study as required;
  12. Patients with a definite history of allergy to embolization materials such as nitinol alloy and/or cobalt-based alloy, platinum-tungsten alloy, etc.;
  13. Subjects with other comorbidities that restrict their participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the study;
  14. Other conditions in which the investigator considers the patient inappropriate to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy
Subjects in this arm will receive unilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine.
Procedure: Middle meningeal artery embolization
Middle meningeal artery embolization with coils.
Drug: Conventional standard pharmacotherapy for migraine
Conventional standard pharmacotherapy for migraine
Experimental: Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy
Subjects in this arm will receive bilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine.
Procedure: Middle meningeal artery embolization
Middle meningeal artery embolization with coils.
Drug: Conventional standard pharmacotherapy for migraine
Conventional standard pharmacotherapy for migraine
Active Comparator: Conventional Standard Pharmacotherapy
Subjects in this arm will receive only conventional standard pharmacotherapy for migraine, without any middle meningeal artery embolization intervention.
Drug: Conventional standard pharmacotherapy for migraine
Conventional standard pharmacotherapy for migraine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine attack frequency (days / month)
Time Frame: :At baseline,within 90 days, 90-day, 180-day after treatment
Change from baseline in the mean number of migraine days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
:At baseline,within 90 days, 90-day, 180-day after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Migraine attack frequency (times / month)
Time Frame: At baseline, within 90 days, 90-day, 180-day after treatment
Change from baseline in the mean number of migraine attacks per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
At baseline, within 90 days, 90-day, 180-day after treatment
Total headache frequency (days / month)
Time Frame: At baseline, within 90 days after treatment
Change from baseline in the mean number of all headache days per month within 90 days after randomization.
At baseline, within 90 days after treatment
Migraine medication use frequency (days / month)
Time Frame: At baseline, within 90 days, 90-day, 180-day after treatment
Change from baseline in the mean number of migraine medication use days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
At baseline, within 90 days, 90-day, 180-day after treatment
Proportion of ≥50% reduction in migraine days (days/month)
Time Frame: At baseline, within 90 days, 90-day, 180-day after treatment
Proportion of participants with at least a 50% reduction from baseline in the mean number of migraine days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization.
At baseline, within 90 days, 90-day, 180-day after treatment
Numerical Rating Scale for migraine pain severity (NRS) (score/month)
Time Frame: At baseline, within 90 days, 180 days after treatment
Change from baseline in the mean monthly Migraine Pain Severity Score (NRS) within 90 days and within 180 days after randomization.
At baseline, within 90 days, 180 days after treatment
Migraine Disability Assessment Questionnaire (MIDAS) (score/month)
Time Frame: At baseline, within 90 days, 180 days after treatment
Change from baseline in the mean monthly Migraine Disability Assessment Score (MIDAS) within 90 days and within 180 days after randomization.
At baseline, within 90 days, 180 days after treatment
Clinical Global Impression Scale (CGI) (score/month)
Time Frame: At baseline, within 90 days, 180 days after treatment
Change from baseline in the mean monthly Clinical Global Impression (CGI) Scale score within 90 days and within 180 days after randomization.
At baseline, within 90 days, 180 days after treatment
Headache Impact Test (HIT-6) (score/month)
Time Frame: At baseline, within 90 days, 180 days after treatment
Change from baseline in the mean monthly Headache Impact Test-6 (HIT-6) score within 90 days and within 180 days after randomization.
At baseline, within 90 days, 180 days after treatment
Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (score/month)
Time Frame: At baseline, within 90 days, 180 days after treatment
Change from baseline in the mean monthly Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1) score within 90 days and within 180 days after randomization.
At baseline, within 90 days, 180 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital Of Guizhou Medical University

Collaborators

Sichuan Action Medical Technology Co., Ltd.
Juhui Medical Technology (Shenzhen) Co., Ltd.
Beijing Xinke Medical Technology Co., Ltd.

Investigators

  • Study Chair: Zeguang Ren, MD. PhD., The Affiliated Hospital of Guizhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAST-EM-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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