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.
Age 18~80 years old (inclusive), regardless of gender.
Voluntary written informed consent.
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.
Migraine attack frequency of no less than 4 days per month within one month prior to enrollment.
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.
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;
Imaging diagnosis shows acute or chronic subdural hematoma, other acute intracranial lesions and other space-occupying lesions;
Patients planning to undergo surgery within 90 days;
Parallel
Middle meningeal artery embolization
Procedure/SurgeryMiddle meningeal artery embolization with coils.
Conventional standard pharmacotherapy for migraine
DrugConventional 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.
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.
Total headache frequency (days / month)
Change from baseline in the mean number of all headache days per month within 90 days after randomization.
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.
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.
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The Affiliated Hospital Of Guizhou Medical University
Lead sponsor
Sichuan Action Medical Technology Co., Ltd.
Collaborator
Juhui Medical Technology (Shenzhen) Co., Ltd.
Collaborator
Beijing Xinke Medical Technology Co., Ltd.
Collaborator
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