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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Middle meningeal artery embolization with coils.
Conventional standard pharmacotherapy for migraine
Migraine attack frequency (days / month)
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.
Time frame: :At baseline,within 90 days, 90-day, 180-day after treatment
Migraine attack frequency (times / month)
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.
Time frame: At baseline, within 90 days, 90-day, 180-day after treatment
Total headache frequency (days / month)
Change from baseline in the mean number of all headache days per month within 90 days after randomization.
Time frame: At baseline, within 90 days after treatment
Migraine medication use frequency (days / month)
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.
Time frame: At baseline, within 90 days, 90-day, 180-day after treatment
Proportion of ≥50% reduction in migraine days (days/month)
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.
Time frame: At baseline, within 90 days, 90-day, 180-day after treatment
Numerical Rating Scale for migraine pain severity (NRS) (score/month)
Change from baseline in the mean monthly Migraine Pain Severity Score (NRS) within 90 days and within 180 days after randomization.
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Enrollment
150
Time frame: At baseline, within 90 days, 180 days after treatment
Migraine Disability Assessment Questionnaire (MIDAS) (score/month)
Change from baseline in the mean monthly Migraine Disability Assessment Score (MIDAS) within 90 days and within 180 days after randomization.
Time frame: At baseline, within 90 days, 180 days after treatment
Clinical Global Impression Scale (CGI) (score/month)
Change from baseline in the mean monthly Clinical Global Impression (CGI) Scale score within 90 days and within 180 days after randomization.
Time frame: At baseline, within 90 days, 180 days after treatment
Headache Impact Test (HIT-6) (score/month)
Change from baseline in the mean monthly Headache Impact Test-6 (HIT-6) score within 90 days and within 180 days after randomization.
Time frame: At baseline, within 90 days, 180 days after treatment
Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (score/month)
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.
Time frame: At baseline, within 90 days, 180 days after treatment