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

Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine： a Single-arm, Self-control, Open-label, Single-center Trial

This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Procedure: Middle meningeal artery embolization

Detailed Description

This study is a single-arm, self-controlled, open-label, single-center clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The inclusion criteria consist of patients with or without aura migraines, who have experienced persistent, chronic migraines for at least 3 months before screening, and have shown resistance to at least two or more drug treatments, with unsatisfactory therapeutic effects, intolerable side effects, or contraindications. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Guiyang, Guizhou, China, 550001
      • The Affiliated Hospital of Guizhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria：

1. Voluntary written informed consent.
2. Age 18~80 years old (inclusive), regardless of gender.
3. Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition
4. Patients with intractable migraine or refractory headache with migraine duration of more than 3 months and recurring migraine in the past 90 days before screening.
5. Patients who take two or more drugs are not satisfied with the therapeutic effect, the side effects of drug treatment are difficult to tolerate or have contraindications.
6. Headache frequency should be confirmed within 30 days before screening.
7. Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation.

Exclusion criteria：

1. Patients with cervical spondylosis and secondary headaches such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache, other definite causes of headache, or secondary headache.
2. Patients without suitable vascular access.
3. Patients scheduled for surgery within 90 days.
4. The life expectancy of patients is less than 12 months.
5. History of contrast agent allergy.
6. Lactating or pregnant women, or patients with a fertility plan within 1 year.
7. The clinical status of the patient was extremely poor, with an mRS Score ≥4.
8. Participants who had participated in clinical studies of other drugs or medical devices before enrollment and did not meet the primary study endpoint time limit.
9. The investigator judged that the patient had poor compliance and could not complete the study as required.
10. The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy.
11. Patient was allergic to the contrast agent.
12. Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study.
13. Patients have clotting disorders or are on anticoagulant therapy.
14. Patients have a history of opioid addiction.
15. Researchers believe that patients who are not suitable to participate in this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Middle meningeal artery embolization; Middle meningeal artery embolization with coil.	Procedure: Middle meningeal artery embolization; Middle meningeal artery embolization with coil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache attack frequency (times / month and Headache duration）	Record of headache attack frequency (times / month and Headache duration）	At baseline, 90 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Headache attack frequency (days / month)	Record of headache attack frequency (days / month)	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Days of medication in acute phase and dosage	Record of days of medication in acute phase and dosage	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Severity of headache:Visual Analogue Scale	The scale is mainly composed of a 10cm straight line, one end represents 0 (no pain at al), and the other end represents 10(the worst pain)	At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Severity of headache:Numerical Rating Scale	The headache level is rated from 0 (no pain) to 10 (the most severe)	At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache aura(nausea,photophobia,phonophobia) frequency	Record of headache aura	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine Disability Assessment	The Migraine Disability Assessment questionnaire (MIDAS)	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache Impact	Headache Impact Test (HIT-6)	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine-Specific Questionnaire	Migraine-Specific Questionnaire（MSQ）	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Hospital Anxiety and Depression	Hospital Anxiety and Depression Scale(HADS)	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Clinical Global Impression	Clinical Global Impression(CGI)	At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Embolization; Middle meningeal artery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: FAST-EM

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
• product manufactured in and exported from the U.S.: No