Clinical trial NCT06029153: Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine
Official title: Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine： a Single-arm, Self-control, Open-label, Single-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Migraine
Middle meningeal artery
Embolization
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Self-control
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Headache attack frequency (times / month and Headache duration）
timeFrame: At baseline, 90 days after treatment
Secondary outcomes:
measure: Headache attack frequency (days / month)
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Days of medication in acute phase and dosage
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Severity of headache:Visual Analogue Scale
timeFrame: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Severity of headache:Numerical Rating Scale
timeFrame: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Headache aura(nausea,photophobia,phonophobia) frequency
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Migraine Disability Assessment
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Headache Impact
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Migraine-Specific Questionnaire
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Hospital Anxiety and Depression
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
measure: Clinical Global Impression
timeFrame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Other outcomes:
Locations:
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
Study officials:
affiliation: The Affiliated Hospital Of Guizhou Medical University
name: Zeguang Ren, MD. PhD.
role: STUDY_CHAIR
References: