Not yet recruiting NCT07633067

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

No phase Interventional Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Middle meningeal artery embolization, Conventional standard pharmacotherapy for migraine.
Who it may be relevant to: Registry conditions: Migraine. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Procedure Middle meningeal artery embolization
Middle meningeal artery embolization with coils.
Drug Conventional standard pharmacotherapy for migraine
Conventional standard pharmacotherapy for migraine

Primary outcome measures

Migraine attack frequency (days / month) [Time frame: :At baseline,within 90 days, 90-day, 180-day after treatment]

Secondary outcome measures (9)

Migraine attack frequency (times / month) [Time frame: 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]
Migraine medication use frequency (days / month) [Time frame: 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]
Numerical Rating Scale for migraine pain severity (NRS) (score/month) [Time frame: 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]
Clinical Global Impression Scale (CGI) (score/month) [Time frame: 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]
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]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

Tempaku A, Yamauchi S, Ikeda H, Tsubota N, Furukawa H, Maeda D, Kondo K, Nishio A. Usefulness of interventional embolization of the middle meningeal artery for recurrent chronic subdural hematoma: Five cases and a review of the literature. Interv Neuroradiol. 2015 Jun;21(3):366-71. doi: 10.1177/1591019915583224. Epub 2015 May 26. PMID 26015518
Levy D, Moskowitz MA. Meningeal Mechanisms and the Migraine Connection. Annu Rev Neurosci. 2023 Jul 10;46:39-58. doi: 10.1146/annurev-neuro-080422-105509. Epub 2023 Mar 13. PMID 36913712
Lam A, Selvarajah D, Htike SS, Chan S, Lalloo S, Lock G, Redmond K, Leggett D, Mews P. The efficacy of postoperative middle meningeal artery embolization on chronic subdural hematoma - A multicentered randomized controlled trial. Surg Neurol Int. 2023 May 12;14:168. doi: 10.25259/SNI_208_2023. eCollection 2023. PMID 37292400
Xu K, Cui J, Demiraj F, Chen G, Wang Q, Mokin M, Yan Z, Peng H, Huang Y, Peng Z, Xiang X, Chu L, Wu S, Song S, Zheng Y, Wang L, Cai J, Shao Y, Yao Y, Yang H, Ren Z. Middle meningeal artery embolization for migraine headaches - a prospective self-control cohort trial. Int J Surg. 2026 Feb 1;112(2):3399-3411. doi: 10.1097/JS9.0000000000003714. Epub 2025 Nov 4. PMID 41186515
Catapano JS, Karahalios K, Srinivasan VM, Baranoski JF, Rutledge C, Cole TS, Ducruet AF, Albuquerque FC, Jadhav AP. Chronic headaches and middle meningeal artery embolization. J Neurointerv Surg. 2022 Mar;14(3):301-303. doi: 10.1136/neurintsurg-2021-017602. Epub 2021 Apr 22. PMID 33888570
Valdueza JM, Dreier JP, Woitzik J, Dohmen C, Sakowitz O, Platz J, Leistner-Glaess S, Witt VD. Course of Preexisting Migraine Following Spontaneous Subarachnoid Hemorrhage. Front Neurol. 2022 Jul 11;13:880856. doi: 10.3389/fneur.2022.880856. eCollection 2022. PMID 35899261
Fan Z, Fan Z, Wang H. New surgical approach for migraine. Otol Neurotol. 2006 Aug;27(5):713-5. doi: 10.1097/01.mao.0000226304.66822.6d. PMID 16868520
Mancuso-Marcello M, Qureshi AI, Nikola C, Stoian I, Jia Y, Saeed D, Bhogal P. Intra-arterial lidocaine therapy via the middle meningeal artery for migraine headache: Theory, current practice and future directions. Interv Neuroradiol. 2026 Feb;32(1):104-108. doi: 10.1177/15910199231195470. Epub 2023 Aug 13. PMID 37574789

Identifiers

NCT: NCT07633067 · FAST-EM-2

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗