Migraine
Conditions
Keywords
Migraine, Middle meningeal artery, Embolization
Brief summary
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.
Detailed description
This study is a multicenter, prospective, double-blind, multi-arm, randomized controlled trial that investigates whether middle meningeal artery embolization is superior to current standard pharmacotherapy for migraine. The main objectives of the study are to explore whether middle meningeal artery embolization can reduce migraine patients' dependence on migraine medications and to assess the safety of middle meningeal artery embolization with coils.This study will enroll 150 subjects with a long history of headache from multiple clinical centers, who will be randomly assigned using a stratified randomization method via computer and web-based software. Stratified randomization will be performed according to study centers (different sub-centers). Subjects will be randomly allocated in a 1:1:1 ratio to the unilateral embolization group, bilateral embolization group, or conventional pharmacotherapy group (hereinafter referred to as the "control group"), with 50 subjects in each group. The unilateral embolization group will receive unilateral MMA interventional embolization plus conventional pharmacotherapy, the bilateral embolization group will receive bilateral MMA interventional embolization plus conventional pharmacotherapy, and the control group will receive only conventional standard pharmacotherapy. Baseline data prior to randomization and data on primary and secondary endpoint scores will be collected for all enrolled subjects. Regular follow-up will be conducted to evaluate the recovery of headache.
Interventions
PROCEDUREMiddle meningeal artery embolization
Middle meningeal artery embolization with coils.
DRUGConventional standard pharmacotherapy for migraine
Conventional standard pharmacotherapy for migraine
Sponsors
The Affiliated Hospital Of Guizhou Medical University
Sichuan Action Medical Technology Co., Ltd.
Juhui Medical Technology (Shenzhen) Co., Ltd.
Beijing Xinke Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
randomized controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18\~80 years old (inclusive), regardless of gender. 2. Voluntary written informed consent. 3. Migraine diagnosed by neurologists/pain specialists according to the current International Classification of Headache Disorders, 3rd Edition (ICHD-3) criteria for migraine with or without aura. 4. Migraine attack frequency of no less than 4 days per month within one month prior to enrollment. 5. History of pharmacotherapy for migraine prophylaxis or treatment for at least 6 months.
Exclusion criteria
1. Findings on cerebral angiography indicating secondary headache due to intracranial vascular disorders, including dural arteriovenous fistula, arteriovenous malformation, venous malformation, or other relevant cerebrovascular lesions; Moyamoya disease; or high-risk vascular anatomical variants unsuitable for safe vascular access or contraindicating MMA embolization. 2. Complicated with cervical spondylosis and secondary headache of otogenic, rhinogenic, odontogenic origin; patients with a history of trigeminal autonomic cephalalgias; headache with other definite etiologies or secondary headache; 3. Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions; 4. Patients planning to undergo surgery within 90 days; 5. Patients with a life expectancy of less than 12 months; 6. Patients with a definite history of contrast media allergy; 7. Patients with a history of opioid addiction; 8. Breastfeeding or pregnant women, or patients with fertility plans within half a year; 9. Subjects who participated in other clinical trials of drugs or medical devices before enrollment and did not reach the time limit of the primary study endpoint; 10. Unable to understand headache-related assessment data such as headache diaries and requiring assistance from others to complete them; 11. Patients with poor compliance judged by the investigator and unable to complete the study as required; 12. Patients with a definite history of allergy to embolization materials such as nitinol alloy and/or cobalt-based alloy, platinum-tungsten alloy, etc.; 13. Subjects with other comorbidities that restrict their participation in the study, prevent compliance with follow-up, or affect the scientific integrity of the study; 14. Other conditions in which the investigator considers the patient inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine attack frequency (days / month) | :At baseline,within 90 days, 90-day, 180-day after treatment | Change from baseline in the mean number of migraine days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Migraine attack frequency (times / month) | At baseline, within 90 days, 90-day, 180-day after treatment | Change from baseline in the mean number of migraine attacks per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization. |
| Total headache frequency (days / month) | At baseline, within 90 days after treatment | Change from baseline in the mean number of all headache days per month within 90 days after randomization. |
| Migraine medication use frequency (days / month) | At baseline, within 90 days, 90-day, 180-day after treatment | Change from baseline in the mean number of migraine medication use days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization. |
| Proportion of ≥50% reduction in migraine days (days/month) | At baseline, within 90 days, 90-day, 180-day after treatment | Proportion of participants with at least a 50% reduction from baseline in the mean number of migraine days per month within 90 days, at the 90-day visit, and at the 180-day visit after randomization. |
| Numerical Rating Scale for migraine pain severity (NRS) (score/month) | At baseline, within 90 days, 180 days after treatment | Change from baseline in the mean monthly Migraine Pain Severity Score (NRS) within 90 days and within 180 days after randomization. |
| Migraine Disability Assessment Questionnaire (MIDAS) (score/month) | At baseline, within 90 days, 180 days after treatment | Change from baseline in the mean monthly Migraine Disability Assessment Score (MIDAS) within 90 days and within 180 days after randomization. |
| Clinical Global Impression Scale (CGI) (score/month) | At baseline, within 90 days, 180 days after treatment | Change from baseline in the mean monthly Clinical Global Impression (CGI) Scale score within 90 days and within 180 days after randomization. |
| Headache Impact Test (HIT-6) (score/month) | At baseline, within 90 days, 180 days after treatment | Change from baseline in the mean monthly Headache Impact Test-6 (HIT-6) score within 90 days and within 180 days after randomization. |
| Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (score/month) | At baseline, within 90 days, 180 days after treatment | Change from baseline in the mean monthly Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1) score within 90 days and within 180 days after randomization. |
Contacts
CONTACTZeguang Ren, MD. PhD.
CONTACTJunshuan Cui, MD.
STUDY_CHAIRZeguang Ren, MD. PhD.
The Affiliated Hospital Of Guizhou Medical University
Outcome results
None listed