MigraineNCT07044648
Middle Meningeal Artery Embolization for Chronic Migraine
A study testing Middle Meningeal Artery Embolization in people with Migraine, run by Wake Forest University Health Sciences.
Trial summary
The main goal of this study is to find out how well middle meningeal artery coil embolization works for patients with recurrent chronic migraines that are not resolved with medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Middle Meningeal Artery Embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with diagnosis of migraine with or without aura, chronic migraine, unilateral or bilateral, moderate to severe intensity, 4-72 hours, familiar or sporadic, status migrainosus, primary or secondary
- Patient who failed pharmacologic treatment (at least 2 failed drugs treatment for more than 3 months) or have considerable side effects
- Patient with diagnosis of migraine and preference for embolization treatment
- Clinical follow up of at least 3 months
- Baseline computed tomography head (CTH) or MR brain which rule out additional intracranial pathology (patient with baseline intracranial pathology other than migraine will be excluded; see the exclusion criteria section below)
- Presence of patent middle meningeal artery homolateral to the side of migraine
Who cannot join
- Previous middle meningeal artery embolization for subdural hematoma
- Previous craniotomy
- Patients aged 17 years or younger.
- Incomplete embolization of middle meningeal artery
- Patient with baseline CTH or MR brain showing baseline intracranial pathology that can explain migraine
About this study
Official title: Middle Meningeal Artery Embolization for Treatment of Chronic Migraine: A Pilot Study
The main goal of this study is to find out how well middle meningeal artery coil embolization works for patients with recurrent chronic migraines that are not resolved with medication.
Read the detailed description
This study seeks to evaluate the therapeutic potential of middle meningeal artery coil embolization as an interventional strategy for patients with recurrent and pharmacoresistant chronic migraine. Middle meningeal artery embolization has recently gained recognition as a safe and effective intervention for the management of chronic subdural hematoma, demonstrating a low complication profile. The procedure achieves therapeutic effect by reducing or occluding arterial flow within the middle meningeal artery, thereby minimizing arterial dilatation and facilitating hematoma resorption over time.
- Conditions
- Migraine
- Being tested
- Middle Meningeal Artery Embolization
- Keywords
- chronic migraine, drug-resistant migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Meningeal Artery EmbolizationProcedure or surgery
Middle meningeal artery embolization using particles or coils
| Study group | Role | What they receive |
|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Participants receive middle meningeal artery embolization Receives: Procedure: Middle Meningeal Artery Embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine Disability Assessment (MIDAS)
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Measured: Baseline
Migraine Disability Assessment (MIDAS)
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Measured: 1 Hour Post Procedure
Migraine Disability Assessment (MIDAS)
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Measured: Day 15 Follow Up
Migraine Disability Assessment (MIDAS)
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Measured: Month 3 Follow Up
Migraine Disability Assessment (MIDAS)
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Measured: Month 6 Follow Up
Migraine Disability Assessment (MIDAS)
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Measured: Month 12 Follow Up
Migraine Pain Scale
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Measured: Baseline
Migraine Pain Scale
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Measured: 1 Hour Post Procedure
Migraine Pain Scale
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Measured: Day 15 Follow Up
Migraine Pain Scale
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Measured: Month 3 Follow Up
Migraine Pain Scale
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Measured: Month 6 Follow Up
Migraine Pain Scale
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Measured: Month 12 Follow Up
Secondary outcomes (6)
Number of Pain Meds Used Post Procedure
Number of pain meds used by participant post embolization procedure
Measured: 1 Hour Post Procedure
Number of Pain Meds Used Post Procedure
Number of pain meds used by participant post embolization procedure
Measured: 6 Hours Post Procedure
Number of Pain Meds Used Post Procedure
Number of migraine pain meds used by participant post embolization procedure
Measured: Day 15 Follow Up
Number of Pain Meds Used Post Procedure
Number of migraine pain meds used by participant post embolization procedure
Measured: Month 3 Follow Up
Number of Pain Meds Used Post Procedure
Number of migraine pain meds used by participant post embolization procedure
Measured: Month 6 Follow Up
Number of Pain Meds Used Post Procedure
Number of migraine pain meds used by participant post embolization procedure
Measured: Month 12 Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study startFeb 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: IRB submission never completed, study application withdrawn by IRB due to lack of response from PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hamad Farhat, MD, Principal investigator, advocate christ medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044648
- Sponsor's protocol ID
- IRB00131621
- Status last verified
- Jan 2026
- First submitted
- 23 Jun 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Meningeal Artery Embolization for Treatment of Chronic Migraine: A Pilot Study
- ClinicalTrials.gov ID
- NCT07044648
- Acronym / sponsor ID
- IRB00131621
- Conditions
- Migraine
- Keywords
- chronic migraine, drug-resistant migraine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB submission never completed, study application withdrawn by IRB due to lack of response from PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to find out how well middle meningeal artery coil embolization works for patients with recurrent chronic migraines that are not resolved with medication.
Detailed description
This study seeks to evaluate the therapeutic potential of middle meningeal artery coil embolization as an interventional strategy for patients with recurrent and pharmacoresistant chronic migraine. Middle meningeal artery embolization has recently gained recognition as a safe and effective intervention for the management of chronic subdural hematoma, demonstrating a low complication profile. The procedure achieves therapeutic effect by reducing or occluding arterial flow within the middle meningeal artery, thereby minimizing arterial dilatation and facilitating hematoma resorption over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle Meningeal Artery Embolization | Experimental | Procedure: Middle Meningeal Artery EmbolizationParticipants receive middle meningeal artery embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with diagnosis of migraine with or without aura, chronic migraine, unilateral or bilateral, moderate to severe intensity, 4-72 hours, familiar or sporadic, status migrainosus, primary or secondary
- Patient who failed pharmacologic treatment (at least 2 failed drugs treatment for more than 3 months) or have considerable side effects
- Patient with diagnosis of migraine and preference for embolization treatment
- Clinical follow up of at least 3 months
- Baseline computed tomography head (CTH) or MR brain which rule out additional intracranial pathology (patient with baseline intracranial pathology other than migraine will be excluded; see the exclusion criteria section below)
Key exclusion criteria (5 listed)
- Previous middle meningeal artery embolization for subdural hematoma
- Previous craniotomy
- Patients aged 17 years or younger.
- Incomplete embolization of middle meningeal artery
- Patient with baseline CTH or MR brain showing baseline intracranial pathology that can explain migraine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle Meningeal Artery EmbolizationMiddle meningeal artery embolization using particles or coils | Procedure or surgery | Middle Meningeal Artery Embolization |
Primary outcome
Migraine Disability Assessment (MIDAS)
Time frame: Baseline
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
Time frame: 1 Hour Post Procedure
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
Time frame: Day 15 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
Time frame: Month 3 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
Time frame: Month 6 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Disability Assessment (MIDAS)
Time frame: Month 12 Follow Up
The MIDAS is a 7 item survey. Score range is Grade I-IV with a higher score indicating severe disabling headache.
Migraine Pain Scale
Time frame: Baseline
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
Time frame: 1 Hour Post Procedure
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
Time frame: Day 15 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
Time frame: Month 3 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
Time frame: Month 6 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
Migraine Pain Scale
Time frame: Month 12 Follow Up
Migraine pain scale range is 1-10 with a higher indicating severe level of pain.
6 secondary outcomes
Number of Pain Meds Used Post Procedure
Time frame: 1 Hour Post Procedure
Number of Pain Meds Used Post Procedure
Time frame: 6 Hours Post Procedure
Number of Pain Meds Used Post Procedure
Time frame: Day 15 Follow Up
Number of Pain Meds Used Post Procedure
Time frame: Month 3 Follow Up
Number of Pain Meds Used Post Procedure
Time frame: Month 6 Follow Up
Number of Pain Meds Used Post Procedure
Time frame: Month 12 Follow Up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamad Farhat, MD principal investigator
advocate christ medical center
Questions about this trial
What is this clinical trial studying?
A study testing Middle Meningeal Artery Embolization in people with Migraine, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine Disability Assessment (MIDAS) (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.