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

December 28, 2024 updated by: Zeguang Ren, The Affiliated Hospital Of Guizhou Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zeguang Ren, MD. PhD.
  • Phone Number: +8613373419258
  • Email: renzem@gmail.com

Study Contact Backup

Study Locations

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Headache attack frequency (times / month and Headache duration）
Time Frame: At baseline, 90 days after treatment
Record of headache attack frequency (times / month and Headache duration）
At baseline, 90 days after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Headache attack frequency (days / month)
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
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
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
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
Time Frame: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
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
Time Frame: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
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
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Record of headache aura
At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine Disability Assessment
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
The Migraine Disability Assessment questionnaire (MIDAS)
At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache Impact
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache Impact Test (HIT-6)
At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine-Specific Questionnaire
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine-Specific Questionnaire（MSQ）
At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Hospital Anxiety and Depression
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Hospital Anxiety and Depression Scale(HADS)
At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Clinical Global Impression
Time Frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Clinical Global Impression(CGI)
At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Hospital Of Guizhou Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zeguang Ren, MD. PhD., The Affiliated Hospital of Guizhou Medical University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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