Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000597493
Ethics application status
Approved
Date submitted
24/06/2024
Date registered
10/06/2025
Date last updated
10/06/2025
Date data sharing statement initially provided
10/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Does middle meningeal artery embolisation reduce headache severity in adults with chronic migraine?
Scientific title
Evaluate the safety and Efficacy of Middle Meningeal Artery Embolisation in Chronic Migraine Patients.
Secondary ID [1] 312397 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MOMENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Migraine 334205 0
Condition category
Condition code
Neurological 330868 330868 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328900 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338628 0
Change in number or severity of migraines
Timepoint [1] 338628 0
Assessed daily from the embolisation procedure for 90 days.
Secondary outcome [1] 436718 0
Safety
Timepoint [1] 436718 0
Assessed at day 0, 30 and 90 days post-embolisation.

Eligibility
Key inclusion criteria
18 years of age and over.
< 50 years of age at onset of migraine
2 or more years of history of chronic migraine
8 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 316805 0
Other
Name [1] 316805 0
World Federation of Interventional and Therapeutic Neuroradiology endowment grant and investigator initiated grant
Country [1] 316805 0
Australia
Primary sponsor type
Government body
Name
South West Sydney - Local Health District
Address
Country
Australia
Secondary sponsor category [1] 319030 0
None
Name [1] 319030 0
Address [1] 319030 0
Country [1] 319030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315575 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 315575 0
Ethics committee country [1] 315575 0
Australia
Date submitted for ethics approval [1] 315575 0
21/06/2024
Approval date [1] 315575 0
14/03/2025
Ethics approval number [1] 315575 0
2024-06-810

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135126 0
Dr Nathan Manning
Address 135126 0
The MIRI centre, Ingham institute. 1 Campbell street Liverpool NSW 2170
Country 135126 0
Australia
Phone 135126 0
+61487214154
Fax 135126 0
Email 135126 0
[email protected]
Contact person for public queries
Name 135127 0
Nathan Manning
Address 135127 0
The MIRI centre, Ingham institute. 1 Campbell street Liverpool NSW 2170
Country 135127 0
Australia
Phone 135127 0
+61487214154
Fax 135127 0
Email 135127 0
[email protected]
Contact person for scientific queries
Name 135128 0
Nathan Manning
Address 135128 0
The MIRI centre, Ingham institute. 1 Campbell street Liverpool NSW 2170
Country 135128 0
Australia
Phone 135128 0
+61487214154
Fax 135128 0
Email 135128 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.