MigraineFAST-EMNCT06029153
Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine
A study testing Middle meningeal artery embolization in people with Migraine, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
Trial summary
This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to evaluate the effectiveness and safety of the treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 15 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 30 Nov 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent.
- Age 18~80 years old (inclusive), regardless of gender.
- Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition
- Patients with intractable migraine or refractory headache with migraine duration of more than 3 months and recurring migraine in the past 90 days before screening.
- Patients who take two or more drugs are not satisfied with the therapeutic effect, the side effects of drug treatment are difficult to tolerate or have contraindications.
- Headache frequency should be confirmed within 30 days before screening.
- Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation.
Who cannot join
- Patients with cervical spondylosis and secondary headaches such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache, other definite causes of headache, or secondary headache.
- Patients without suitable vascular access.
- Patients scheduled for surgery within 90 days.
- The life expectancy of patients is less than 12 months.
- History of contrast agent allergy.
- Lactating or pregnant women, or patients with a fertility plan within 1 year.
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- The clinical status of the patient was extremely poor, with an mRS Score ≥4.
- Participants who had participated in clinical studies of other drugs or medical devices before enrollment and did not meet the primary study endpoint time limit.
- The investigator judged that the patient had poor compliance and could not complete the study as required.
- The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy.
- Patient was allergic to the contrast agent.
- Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study.
- Patients have clotting disorders or are on anticoagulant therapy.
- Patients have a history of opioid addiction.
- Researchers believe that patients who are not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001
About this study
Official title: Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine： a Single-arm, Self-control, Open-label, Single-center Trial
This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
Read the detailed description
This study is a single-arm, self-controlled, open-label, single-center clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The inclusion criteria consist of patients with or without aura migraines, who have experienced persistent, chronic migraines for at least 3 months before screening, and have shown resistance to at least two or more drug treatments, with unsatisfactory therapeutic effects, intolerable side effects, or contraindications. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
- Conditions
- Migraine
- Being tested
- Middle meningeal artery embolization
- Keywords
- Migraine, Middle meningeal artery, Embolization
- 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 with coil.
| Study group | Role | What they receive |
|---|---|---|
| Middle meningeal artery embolization | Experimental | Middle meningeal artery embolization with coil. Receives: Procedure: Middle meningeal artery embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache attack frequency (times / month and Headache duration）
Record of headache attack frequency (times / month and Headache duration）
Measured: At baseline, 90 days after treatment
Secondary outcomes (10)
Headache attack frequency (days / month)
Record of headache attack frequency (days / month)
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Days of medication in acute phase and dosage
Record of days of medication in acute phase and dosage
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Severity of headache:Visual Analogue Scale
The scale is mainly composed of a 10cm straight line, one end represents 0 (no pain at al), and the other end represents 10(the worst pain)
Measured: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Severity of headache:Numerical Rating Scale
The headache level is rated from 0 (no pain) to 10 (the most severe)
Measured: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache aura(nausea,photophobia,phonophobia) frequency
Record of headache aura
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine Disability Assessment
The Migraine Disability Assessment questionnaire (MIDAS)
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache Impact
Headache Impact Test (HIT-6)
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine-Specific Questionnaire
Migraine-Specific Questionnaire（MSQ）
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Hospital Anxiety and Depression
Hospital Anxiety and Depression Scale(HADS)
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Clinical Global Impression
Clinical Global Impression(CGI)
Measured: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start15 Jun 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
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.
- 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
- Model description
- Self-control
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeguang Ren, The Affiliated Hospital Of Guizhou Medical University
- Investigators
- Zeguang Ren, MD. PhD., Study chair, The Affiliated Hospital Of Guizhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029153
- Sponsor's protocol ID
- FAST-EM
- Acronym
- FAST-EM
- Status last verified
- May 2024
- First submitted
- 1 Sep 2023
- Last updated
- 31 Dec 2024
- 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 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine： a Single-arm, Self-control, Open-label, Single-center Trial
- ClinicalTrials.gov ID
- NCT06029153
- Acronym / sponsor ID
- FAST-EM / FAST-EM
- Conditions
- Migraine
- Keywords
- Migraine, Middle meningeal artery, Embolization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Affiliated Hospital Of Guizhou Medical UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 8 Sep 2023 (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.
This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
Detailed description
This study is a single-arm, self-controlled, open-label, single-center clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The inclusion criteria consist of patients with or without aura migraines, who have experienced persistent, chronic migraines for at least 3 months before screening, and have shown resistance to at least two or more drug treatments, with unsatisfactory therapeutic effects, intolerable side effects, or contraindications. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self-control
| Arm | Type | Receives |
|---|---|---|
| Middle meningeal artery embolization | Experimental | Procedure: Middle meningeal artery embolizationMiddle meningeal artery embolization with coil. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntary written informed consent.
- Age 18~80 years old (inclusive), regardless of gender.
- Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition
- Patients with intractable migraine or refractory headache with migraine duration of more than 3 months and recurring migraine in the past 90 days before screening.
- Patients who take two or more drugs are not satisfied with the therapeutic effect, the side effects of drug treatment are difficult to tolerate or have contraindications.
Key exclusion criteria (15 listed)
- Patients with cervical spondylosis and secondary headaches such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache, other definite causes of headache, or secondary headache.
- Patients without suitable vascular access.
- Patients scheduled for surgery within 90 days.
- The life expectancy of patients is less than 12 months.
- History of contrast agent allergy.
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 with coil. | Procedure or surgery | Middle meningeal artery embolization |
Primary outcome
Headache attack frequency (times / month and Headache duration）
Time frame: At baseline, 90 days after treatment
Record of headache attack frequency (times / month and Headache duration）
10 secondary outcomes
Headache attack frequency (days / month)
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Days of medication in acute phase and dosage
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Severity of headache:Visual Analogue Scale
Time frame: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Severity of headache:Numerical Rating Scale
Time frame: At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache aura(nausea,photophobia,phonophobia) frequency
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine Disability Assessment
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Headache Impact
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Migraine-Specific Questionnaire
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Hospital Anxiety and Depression
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Clinical Global Impression
Time frame: At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- 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.
Zeguang Ren, MD. PhD. study chair
The Affiliated Hospital Of Guizhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle meningeal artery embolization in people with Migraine, run by The Affiliated Hospital Of Guizhou Medical University at 1 site in China.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Headache attack frequency (times / month and Headache duration） (time frame: At baseline, 90 days after treatment). 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 31 Dec 2024.