Clinical trial for Refractory Migraine
Official title Localized Injection of Lidocaine Via the Middle Meningeal Artery for Headache Treatment
ClinicalTrials.gov ID: NCT07361549
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 refractory migraine.
Also referred to as Xylocaine.
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 goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines)
- 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 and older
You may be able to join if
- Age 18 years or above
- Diagnosis of chronic migraine
- Referred for diagnostic cerebral angiography to screen for intracranial pathology
- Written informed consent able to be obtained from subject
You likely can't join if
- Baseline HIT-6 score less than 50
- Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Concomitant intracranial pathology (eg, intracranial malignancy)
- Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
- Taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing...
See the full eligibility criteria
- Age 18 years or above
- Diagnosis of chronic migraine
- Referred for diagnostic cerebral angiography to screen for intracranial pathology
- Written informed consent able to be obtained from subject
- Baseline HIT-6 score less than 50
- Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- Concomitant intracranial pathology (eg, intracranial malignancy)
- Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
- Taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing methemoglobinemia (nitrates/nitrites, local anesthetics, antineoplastic agents...
- Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids.
- Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC)
- Concurrent participation in another research protocol for investigation of an experimental therapy
- Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula)
- Per DSA imaging, presence of anastomosis or anatomical variation (eg, branches of middle meningeal artery) that could lead to increased procedural risk
- Per DSA imaging, lack of endovascular access to either middle meningeal artery, or origin of the middle meningeal artery other than from the external carotid artery
- Known or suspected inability to adhere to study protocol or protocol requirements, as per discretion of the Investigator or treating provider
The study team makes the final eligibility decision.
Where it's taking place
- Camden, New Jersey, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Camden, New Jersey, 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.