Safety and Efficacy of Middle Meningeal Artery Embolization for the Treatment of Migraine.

NCT07633067 | Not Yet Recruiting DMC

• 1 other identifier: FAST-EM-2
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine

Keywords

Migraine; Middle meningeal artery; Embolization

Outcome Measures

Primary Outcomes (1)

• Migraine attack frequency (days / month)

  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 Outcomes (9)

• Migraine attack frequency (times / month)

  At baseline, within 90 days, 90-day, 180-day after treatment

• Total headache frequency (days / month)

  At baseline, within 90 days after treatment

• Migraine medication use frequency (days / month)

  At baseline, within 90 days, 90-day, 180-day after treatment

• Proportion of ≥50% reduction in migraine days (days/month)

  At baseline, within 90 days, 90-day, 180-day after treatment

• Numerical Rating Scale for migraine pain severity (NRS) (score/month)

  At baseline, within 90 days, 180 days after treatment

Study Arms (3)

Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy

EXPERIMENTAL

Subjects in this arm will receive unilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine.

Procedure: Middle meningeal artery embolization; Drug: Conventional standard pharmacotherapy for migraine

Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy

EXPERIMENTAL

Subjects in this arm will receive bilateral middle meningeal artery embolization with coils plus conventional standard pharmacotherapy for migraine.

Procedure: Middle meningeal artery embolization; Drug: Conventional standard pharmacotherapy for migraine

Conventional Standard Pharmacotherapy

ACTIVE COMPARATOR

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

Interventions

Middle meningeal artery embolization PROCEDURE

Middle meningeal artery embolization with coils.

Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy; Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy

Conventional standard pharmacotherapy for migraine DRUG

Conventional standard pharmacotherapy for migraine

Bilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy; Conventional Standard Pharmacotherapy; Unilateral Middle Meningeal Artery Embolization + Standard Pharmacotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18\~80 years old (inclusive), regardless of gender.
• Voluntary written informed consent.
• 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.
• Migraine attack frequency of no less than 4 days per month within one month prior to enrollment.
• History of pharmacotherapy for migraine prophylaxis or treatment for at least 6 months.

You may not qualify if:

• 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.
• 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;
• Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions;
• Patients planning to undergo surgery within 90 days;
• Patients with a life expectancy of less than 12 months;
• Patients with a definite history of contrast media allergy;
• Patients with a history of opioid addiction;
• Breastfeeding or pregnant women, or patients with fertility plans within half a year;
• 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;
• Unable to understand headache-related assessment data such as headache diaries and requiring assistance from others to complete them;
• Patients with poor compliance judged by the investigator and unable to complete the study as required;
• Patients with a definite history of allergy to embolization materials such as nitinol alloy and/or cobalt-based alloy, platinum-tungsten alloy, etc.;
• Subjects with other comorbidities that restrict their participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the study;
• Other conditions in which the investigator considers the patient inappropriate to participate in this study.

Sponsors & Collaborators

• Juhui Medical Technology (Shenzhen) Co., Ltd.: collaborator
• The Affiliated Hospital Of Guizhou Medical University: lead
• Sichuan Action Medical Technology Co., Ltd.: collaborator
• Beijing Xinke Medical Technology Co., Ltd.: collaborator

Related Publications (34)

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MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Zeguang Ren, MD. PhD.

  The Affiliated Hospital Of Guizhou Medical University

  STUDY CHAIR

Central Study Contacts

Zeguang Ren, MD. PhD.

CONTACT

+86 0851-86770232.; renzem@gmail.com

Junshuan Cui, MD.

CONTACT

+8615761600325; junshuan2306@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, principle investigator, Department of Neurosurgery

Model Details: randomized controlled

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share