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

NCT06029153 | Completed

• 1 other identifier: FAST-EM
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Keywords

Migraine; Middle meningeal artery; Embolization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

  At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment

• Severity of headache:Visual Analogue Scale

  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

  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

  At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment

Study Arms (1)

Middle meningeal artery embolization

EXPERIMENTAL

Middle meningeal artery embolization with coil.

Procedure: Middle meningeal artery embolization

Interventions

Middle meningeal artery embolization PROCEDURE

Middle meningeal artery embolization with coil.

Middle meningeal artery embolization

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital Of Guizhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Self-control

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: June 15, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)