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New treatment option for Migraine
Official title Bilateral Embolization of the Middle Meningeal Arteries for Refractory Chronic Migraine
ClinicalTrials.gov ID: NCT07223008
What this study is testing
- What it's testing
- This study is to test the safety and feasibility of a procedure called embolization of the middle meningeal arteries (MMA), using a product called Onyx. Embolization creates a plug in the arteries.
- Time commitment: about 8 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18\<x\<80
- Meets ICHD3 criteria for chronic migraine, (ICHD3, 1.3; with inclusion of ICHD3 1.1 and 1.2.1 only), with first migraine before age 50 (in...
- Satisfy criteria for refractory chronic migraine defined as failure of, inadequate response to, or inability to tolerate migraine preventatives in at...
- Has not used opiates or barbiturates as acute (rescue) therapy for migraine headache. Opiate or barbiturate use for reasons other than migraine is...
- Exclusion of secondary headache disorder which may cause migraines/symptoms, including MRI/MRA (performed as routine care showing no underlying...
You likely can't join if
- History of cranial or cervical vascular interventions or surgery, including craniotomy/craniectomy, shunt placement, stereoelectroencephalography...
- A history of opiate or barbiturate use for the treatment of chronic migraine within one year.
- Current intracranial lesions as determined by routine care MRI for exclusion of secondary headache disorders.
- History of cranial radiation treatment.
- Patients with additional diagnoses under ICHD3 (such as hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache)...
- Significant liver function impairment or serum creatinine \> 2.0 mg/dL. Patients with elevated creatinine levels who are on dialysis may be eligible.
See the full eligibility criteria
Who can join
- Age 18\<x\<80
- Meets ICHD3 criteria for chronic migraine, (ICHD3, 1.3; with inclusion of ICHD3 1.1 and 1.2.1 only), with first migraine before age 50 (in concordance with previously published trials in migraine therapy36,39)...
- Satisfy criteria for refractory chronic migraine defined as failure of, inadequate response to, or inability to tolerate migraine preventatives in at least 2 classes. Migraine preventatives include beta-blockers...
- Has not used opiates or barbiturates as acute (rescue) therapy for migraine headache. Opiate or barbiturate use for reasons other than migraine is allowed. Other classes of acute migraine medications are acceptable...
- Exclusion of secondary headache disorder which may cause migraines/symptoms, including MRI/MRA (performed as routine care showing no underlying lesion that may be causing headaches, within 3 years of screening).
- At least one migraine free day during the last month per headache diary.
- Minimum MIDAS score of 21 (reflecting severely disabling migraine, in concordance with ongoing MMA lidocaine infusion trial44).
- Able to read/write in English. Patients who are not English language users will not be enrolled as the study assessments are only validated in English.
- Able to sign informed consent for themselves.
- Able to complete study requirements/follow-up as outlined in study plan section 3.6.
What rules you out
- History of cranial or cervical vascular interventions or surgery, including craniotomy/craniectomy, shunt placement, stereoelectroencephalography, and carotid endarterectomy.
- A history of opiate or barbiturate use for the treatment of chronic migraine within one year.
- Current intracranial lesions as determined by routine care MRI for exclusion of secondary headache disorders.
- History of cranial radiation treatment.
- Patients with additional diagnoses under ICHD3 (such as hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache) are ineligible
- Significant liver function impairment or serum creatinine \> 2.0 mg/dL. Patients with elevated creatinine levels who are on dialysis may be eligible.
- History of systemic malignancy or auto-immune inflammatory disorders (such as multiple sclerosis, rheumatoid arthritis, autoimmune diseases).
- History of life-threatening allergy to radiographic contrast. Patients with this allergy may be eligible if it can be managed medically.
- Enrollment in another migraine study which could confound this study's endpoints, including undergoing any intervention or receiving an experimental drug under investigation for migraine therapy.
- Additional medical or social concerns which could confound this study's endpoints or otherwise create undue risk or interfere with the participant's ability to complete the study, as assessed by the PI.
- As this study is open only to patients with chronic migraine, which is refractory to treatment, patients who have previously been diagnosed with chronic migraine but now experience episodic migraine due to effective...
- Patients with additional diagnoses under ICHD3 (such as hemiplegic migraine, basilar migraine, new daily persistent headache, or cluster headache) are ineligible.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.