RecruitingPhase 2

Bilateral Middle Meningeal Artery Lidocaine Infusion for Chronic Debilitating Migraines

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This treatment is an intra-arterial bilateral lidocaine infusion into the middle meningeal artery (i.e. this is a lidocaine infusion into the brain blood vessels to turn off the pain receptors responsible for causing chronic headaches)."
  • "Intra-arterial lidocaine infusion has been used safely during the treatment of other brain diseases."
  • "During the intra-arterial infusion of lidocaine for treatment of a subdural procedure, an incidental finding noted that patients had reduced headache intensity following this treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether lidocaine, a numbing medicine, can make chronic migraines less painful, less frequent, or shorter. The medicine is given into blood vessels inside the skull. The study is for adults ages 18 to 75 with very severe headaches that have not improved with several treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old and have had a chronic daily headache diagnosis for at least 12 months.
  • You have had more than 15 headache days a month for at least 3 months, with an average of at least 15 days a month in the 3 months before screening.
  • At least 3 treatments to prevent headaches have failed.
  • Your headaches greatly limit daily life: a headache disability score of at least 21 and a migraine severity score of 6 or 7.
  • At least half of your headaches have pain above 5 on a pain scale.
  • Your current prevention treatment causes side effects you cannot tolerate or has not helped enough after 6 weeks at a usual treatment dose.
  • Your other medicines and headache prevention medicines have stayed the same for 3 months before screening.
  • During the starting period, you must have at least 15 headache days a month, complete more than 75% of diary entries over 28 days or longer, and still meet the study rules.

Who can't join

  • You started a new migraine prevention treatment in the past 3 months, are allergic or sensitive to lidocaine, or have not removed a Lidoderm pain patch at least 3 days before treatment.
  • You have a severe allergy to iodine-based scan dye, a problem inside the skull seen on a brain scan within 12 months, or a long-lasting blood collection around the brain.
  • You had a stroke from blocked blood flow or a heart attack in the past 3 months, or poor kidney function with a creatinine blood test above 1.5 during that time. Kidney testing will be repeated.
  • You have certain abnormal heart electrical tests from the past 3 months, take medicines that can delay the heart's electrical recovery, or take heart rhythm medicines other than beta blockers.
  • You have symptoms from poor blood flow in the arms or legs, or a bleeding disorder. Taking medicines that prevent blood clots alone does not count as a bleeding disorder.
  • You have an active substance use or addiction disorder, used illegal drugs for recreation, or had these issues within 12 months. Other ongoing pain conditions, such as fibromyalgia or long-term pelvic pain, also exclude you.
  • You have a history of a major mental health disorder or a depression screening score of 15 or higher. Some people with anxiety or depression may qualify with a score below 15 and no more than 1 medicine for each condition for at least 2 months.
  • You are pregnant or plan to become pregnant or make your partner pregnant during the study; the listing includes an exception when proper birth control is in place. You also cannot join if the study doctor finds a condition that makes the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Adults aged 18 to 75 years with a very severe to extremely severe medically refractory Chronic Daily Headache (CDH). 1. Chronic: as defined by the International Headache Society Classification ICHD 3 (\>15 headache days a month for a period of at least 3 months) 2. Medically refractory: defined as failure of ≥3 headache preventative treatments. 3. Severely disabling (Migraine Disability Assessment \[MIDAS\] Tool score of ≥ 21 \[Grade IV\]) 4. Score of 6 (very severe) or 7 (extremely severe) on the Global Assessment of Migraine Severity (GAMS) rating scale. 5. Head pain is at least moderate-to-severe intensity (\>5 on a Visual Analog Scale) in ≥50% of headaches. 2. Diagnosis of CDH for ≥ 12 months before screening based on medical records and/or patient self-report. 3. Headache frequency: minimum 15 monthly headache days (MHD) on average across the 3 months prior to screening 4. 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 generally accept therapeutic dose for 6 weeks). 5. On a stable concomitant medication and headache preventive for the 3 months prior to screening During Baseline Period: 1. Must have ≥ 15 MHD based on the patient self-maintained diary data during the baseline period. 2. 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. 3. Must continue to meet eligibility criteria when reassessed at baseline completion visit Exclusion Criteria: 1. Recently started new migraine preventative treatment regimen within the past 3 months. 2. Known allergy or sensitivity to lidocaine. 3. Lidoderm patch (not an exclusion if the Lidoderm patch has been removed for ≥ 3 days before the procedure) 4. Severe allergy/anaphylaxis to iodinated contrast dye. 5. Any intracranial pathology on brain imaging (head CT or MRI within the past 12 months) 6. Chronic subdural hematoma 7. 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, specifically: 1. Prolonged QT syndrome 2. 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 inherited or acquired bleeding diathesis (not including antiplatelet or anticoagulation medication) 13\. Evidence of active substance-related disorders, addictive disorders, or "recreational use" of illicit drugs. a. If any of these disorders have occurred within 12 months prior to screening, based on medical records, patient self-report, or positive urine drug test (except for prescribed medications that may result in a positive urine drug test). 14\. Active chronic pain syndromes (e.g., fibromyalgia and chronic pelvic pain). 15\. History of major psychiatric disorder or current evidence of moderately severe or severe depression based on a Patient Health Questionnaire-9 (PHQ-9) total score ≥ 15 at screening. a. Subjects with history of anxiety disorder and/or major depressive disorder with PHQ-9 \< 15) and are taking no more than 1 medication, for each disorder, for at least 2 months prior to screening may be considered. 16\. If the subject is pregnant, planning on pregnancy during the duration of the study, or planning on making their partner pregnant will be excluded from the study unless proper contraception is in place. 17\. Any diagnosis at the discretion of the investigator that would make the patient unfit.

Study sites (1)

NY