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

Primary Purpose

Migraine

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Middle meningeal artery embolization
Sponsored by
Zeguang Ren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Middle meningeal artery, Ambolization, Coil

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Voluntary written informed consent. Age 18~80 years old (inclusive), regardless of gender. Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition 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. 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. Headache frequency should be confirmed within 30 days before screening. Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation. Exclusion criteria: 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. Patients without suitable vascular access. Patients scheduled for surgery within 90 days. The life expectancy of patients is less than 12 months. History of contrast agent allergy. Lactating or pregnant women, or patients with a fertility plan within 1 year. The clinical status of the patient was extremely poor, with an mRS Score ≥4. 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. The investigator judged that the patient had poor compliance and could not complete the study as required. The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy. Patient was allergic to the contrast agent. Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study. Patients have clotting disorders or are on anticoagulant therapy. Patients have a history of opioid addiction. Researchers believe that patients who are not suitable to participate in this trial.

Sites / Locations

  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Middle meningeal artery embolization

Arm Description

Middle meningeal artery embolization with coil.

Outcomes

Primary Outcome Measures

Headache attack frequency (times / month and Headache duration)
Record of headache attack frequency (times / month and Headache duration)

Secondary Outcome Measures

Headache attack frequency (days / month)
Record of headache attack frequency (days / month)
Days of medication in acute phase and dosage
Record of days of medication in acute phase and dosage
Severity of headache
VAS/NRS pain rating scale
Headache aura(nausea,photophobia,phonophobia) frequency
Record of headache aura
Migraine Disability Assessment
Migraine Disability Assessment (MIDAS)
Headache Impact
Headache Impact Test (HIT-6)
Migraine-Specific Questionnaire
Migraine-Specific Questionnaire(MSQ)
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale(HADS)
Patient Clinical Global Impression
At baseline,30 days,and 60 days after treatment(PCGI)

Full Information

First Posted
September 1, 2023
Last Updated
September 1, 2023
Sponsor
Zeguang Ren
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1. Study Identification

Unique Protocol Identification Number
NCT06029153
Brief Title
Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine
Acronym
FAST-EM
Official Title
Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine:a Single-arm, Self-control, Open-label, Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zeguang Ren

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to record and evaluate the effectiveness and safety of the treatment.
Detailed Description
This study is a single-arm, self-controlled clinical trial that aims to explore and evaluate 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 prior to 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 record and evaluate the effectiveness and safety of the treatment.The content that needs to be recorded includes Headache attack frequency (times / month and Headache duration),Headache attack frequency (days / month),Days of medication in acute phase and dosage,Severity of headache,Headache aura(nausea,photophobia,phonophobia) frequency,Migraine Disability Assessment,Headache Impact,Migraine-Specific Questionnaire,Hospital Anxiety and Depression Scale,Patient Clinical Global Impression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Middle meningeal artery, Ambolization, Coil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Middle meningeal artery embolization
Arm Type
Experimental
Arm Description
Middle meningeal artery embolization with coil.
Intervention Type
Procedure
Intervention Name(s)
Middle meningeal artery embolization
Intervention Description
Middle meningeal artery embolization with coil.
Primary Outcome Measure Information:
Title
Headache attack frequency (times / month and Headache duration)
Description
Record of headache attack frequency (times / month and Headache duration)
Time Frame
At baseline and 30 days,60 days after treatment
Secondary Outcome Measure Information:
Title
Headache attack frequency (days / month)
Description
Record of headache attack frequency (days / month)
Time Frame
At baseline, 30 days, and 60 days after treatment
Title
Days of medication in acute phase and dosage
Description
Record of days of medication in acute phase and dosage
Time Frame
At baseline, 30 days, and 60 days after treatment
Title
Severity of headache
Description
VAS/NRS pain rating scale
Time Frame
At baseline,36 hours,day of discharge,30 days,and 60 days after treatment
Title
Headache aura(nausea,photophobia,phonophobia) frequency
Description
Record of headache aura
Time Frame
At baseline,30 days,and 60 days after treatment
Title
Migraine Disability Assessment
Description
Migraine Disability Assessment (MIDAS)
Time Frame
At baseline,30 days,and 60 days after treatment
Title
Headache Impact
Description
Headache Impact Test (HIT-6)
Time Frame
At baseline,30 days,and 60 days after treatment
Title
Migraine-Specific Questionnaire
Description
Migraine-Specific Questionnaire(MSQ)
Time Frame
At baseline,30 days,and 60 days after treatment
Title
Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale(HADS)
Time Frame
At baseline,30 days,and 60 days after treatment
Title
Patient Clinical Global Impression
Description
At baseline,30 days,and 60 days after treatment(PCGI)
Time Frame
Patient Clinical Global Impression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Voluntary written informed consent. Age 18~80 years old (inclusive), regardless of gender. Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition 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. 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. Headache frequency should be confirmed within 30 days before screening. Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation. Exclusion criteria: 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. Patients without suitable vascular access. Patients scheduled for surgery within 90 days. The life expectancy of patients is less than 12 months. History of contrast agent allergy. Lactating or pregnant women, or patients with a fertility plan within 1 year. The clinical status of the patient was extremely poor, with an mRS Score ≥4. 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. The investigator judged that the patient had poor compliance and could not complete the study as required. The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy. Patient was allergic to the contrast agent. Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study. Patients have clotting disorders or are on anticoagulant therapy. Patients have a history of opioid addiction. Researchers believe that patients who are not suitable to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeguang Ren, MD. PhD.
Phone
+8613373419258
Email
renzem@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junshuan Cui, MD.
Phone
+8615761600325
Email
junshuan2306@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeguang Ren, MD. PhD.
Organizational Affiliation
The Affiliated Hospital Of Guizhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeguang Ren, MD. PhD.
Phone
+8615761600325
Email
renzem@gmail.com
First Name & Middle Initial & Last Name & Degree
Junshuan Cui, MD.
Phone
+8615761600325
Email
junshuan2306@163.com
First Name & Middle Initial & Last Name & Degree
Hua Yang, MD.
First Name & Middle Initial & Last Name & Degree
Kaya Xu, MD. PhD.
First Name & Middle Initial & Last Name & Degree
Xin Xiang, MD. PhD.
First Name & Middle Initial & Last Name & Degree
Liangzhao Chu, MD. PhD.
First Name & Middle Initial & Last Name & Degree
Junshuan Cui, MD.

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine

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