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New treatment option for Migraine
Official title Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines
ClinicalTrials.gov ID: NCT07061847
What this study is testing
What is Lidocaine (drug)?
Lidocaine (drug) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to evaluate the effectiveness of a new treatment in improving chronic migraine symptoms. This treatment involves a targeted lidocaine infusion into blood vessels in the skull to numb pain receptors, potentially leading to improvements in chronic migraine intensity, frequency, and duration.
- Phase 2: a mid-size study of how well it works
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 75
You may be able to join if
- Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH).
- Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months)
- Medically refractory: defined as failure of ≥3 headache preventative treatments.
- Severely disabling (Migraine Disability Assessment [MIDAS] Tool score of ≥ 21 [Grade IV])
- Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale.
You likely can't join if
- Recently started new migraine preventative treatment regimen within the past 3 months.
- Known allergy or sensitivity to lidocaine.
- Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure)
- Severe allergy/anaphylaxis to iodinated contrast dye.
- Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months)
- Chronic subdural hematoma
See the full eligibility criteria
- Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH).
- Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months)
- Medically refractory: defined as failure of ≥3 headache preventative treatments.
- Severely disabling (Migraine Disability Assessment [MIDAS] Tool score of ≥ 21 [Grade IV])
- Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale.
- Head pain is at least moderate-to-severe intensity (\>5 on a Visual Analog Scale) in ≥50% of headaches.
- Diagnosis of CDH for ≥ 12 months before screening based on medical records and/or patient self-report.
- Headache frequency: minimum 15 monthly headache days (MHD) on average across the 3 months prior to screening
- Patient reports to their provider intolerance or insufficient response with their current preventive treatment (i.e. insufficient reduction in headache frequency, duration, and severity on a standard treatment on a...
- On a stable concomitant medication and headache preventive for the 3 months prior to screening During Baseline Period:
- Must have ≥ 15 MHD based on the patient self-maintained diary data during the baseline period.
- Must have demonstrated \>75% compliance with diary data for the 28 day duration period, or longer if their baseline period carries on past this point.
- Must continue to meet eligibility criteria when reassessed at baseline completion visit
- Recently started new migraine preventative treatment regimen within the past 3 months.
- Known allergy or sensitivity to lidocaine.
- Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure)
- Severe allergy/anaphylaxis to iodinated contrast dye.
- Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months)
- Chronic subdural hematoma
- Ischemic stroke or myocardial infarction within 3 months 8. History of renal insufficiency with Cr \> 1.5 within 3 months (will be retested during pre-surgical testing). 9\. History of abnormal ECGs within 3 months...
- Prolonged QT syndrome
- Use of medications that may prolong the QT interval such as: anti-nausea, anti-emetics, etc. 10\. Taking any antiarrhythmic medication (other than a beta blocker) 11\. Symptomatic peripheral arterial disease 12\. Known...
The study team makes the final eligibility decision.
Where it's taking place
- Great Neck, New York, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Great Neck, New York, 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.