Not Yet RecruitingPhase 1ACTRN12625000597493

Does middle meningeal artery embolisation reduce headache severity in adults with chronic migraine?

Evaluate the safety and Efficacy of Middle Meningeal Artery Embolisation in Chronic Migraine Patients.

Sponsor

South West Sydney - Local Health District

Enrollment

40 participants

Start Date

Jul 1, 2025

Study Type

Interventional

Conditions

Chronic Migraine

Summary

Middle meningeal artery is an important part of the trigeminovascular system and may be important in migraine pathophysiology. By blocking blood flow to this artery migraine headaches may be reduced in frequency or severity.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria8

years of age and over.
< 50 years of age at onset of migraine
or more years of history of chronic migraine
or more migraine days and at least 15 headaches per month
Failure to respond to at least four classes of migraine medicines
On stable migraine medication treatment
Able to use the eDiary on a mobile phone.
Not pregnant and not planning to become pregnant in the next 3 months

Exclusion Criteria8

History of migraine accompanied by diplopia or decreased consciousness
Confounding and clinically significant pain syndrome
Non-migraine headache syndrome
Psychiatric conditions that are uncontrolled or untreated
History of addiction
Use of opioids more than 10 days a month
Iodine allergy
Female patients planning on becoming pregnant

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Interventions

Dilatation of the middle meningeal artery is linked with headaches in migraine patients. This phase I pilot study assesses the safety and efficacy of bilateral middle meningeal artery embolisation i

Dilatation of the middle meningeal artery is linked with headaches in migraine patients. This phase I pilot study assesses the safety and efficacy of bilateral middle meningeal artery embolisation in chronic migraine patients. The middle meningeal artery will be permanently occluded using a minimally invasive endovascular approach using precipitating hydrophobic injectable liquid (PHIL) embolic (< 1ml) by an investigating neurointerventionalist. For 28 days before and 90 days following bilateral middle meningeal artery occlusion, subjects will complete daily headache assessments using a mobile application (~ 3 minutes). Compliance will be monitored by trial staff.