Clinical trial NCT06462781: Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1
Official title: Intra-Arterial Injection of Lidocaine and Glucocorticoid in the Treatment of Intractable Headaches: A Non-Randomized, Open-Label Phase 1 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Refractory Migraine
Keywords: headache
migraine
lidocaine
glucocorticoid
middle meningeal artery
intra-arterial
status migrainosus
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
Collaborators: name: Society of Vascular and Interventional Neurology
First posted: 2024-06-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).

The main questions this study aims to answer: is this treatment safe for chronic migraine patients?

Participants will:

* Be treated once with lidocaine and steroid infused into the middle meningeal arteries (two blood vessels in the brain).
* Attend appointments scheduled 1 week, 6 weeks, and 12 weeks after the treatment for a checkup.
* Keep a log of their symptoms.


Eligibility criteria: Inclusion Criteria:

* Male or female greater than or equal to 18 years of age.
* Documentation of a diagnosis of intractable migraine without aura, including failure of at least four classes of preventative drugs. Either intolerance or side effects requiring discontinuation or adequate trial at therapeutic dose without relief constitutes failure of therapy.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants, or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
* 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.
* Patients with concomitant intracranial pathology (e.g., intracranial malignancy).
* Blood glucose level on screening complete metabolic blood panel \&amp;amp;gt; 400 mg/dL.
* Patients with known hypersensitivity and/or contraindication to either lidocaine hydrochloride or methylprednisolone sodium succinate, including:
* Patients with known history of hypersensitivity to local anesthetics of the amide type.
* Patients with systemic fungal infections.
* Patients with known or suspected hypersensitivity to cow's milk or its components or other dairy products (SOLU-MEDROL® 40mg presentation includes lactose monohydrate, and may contain trace amounts of milk ingredients).
* Patients 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, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, sulfasalazine.
* Patients taking chronic medications that, when co-administered with methylprednisolone, are at increased risk for hypokalemia, altered drug levels, convulsions, or altered clearance: amphotericin B, diuretics, aminoglutethimide, macrolide antibiotics, anticholinesterases, antitubercular drugs, cholestyramine, cyclosporine, digitalis glycosides, estrogens (including oral contraceptives), hepatic enzyme inducers/inhibitors, and ketoconazole.
* Patients have known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
* Patient has known active systemic infection or sepsis.
* Patient has contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
* Concurrent participation in another research protocol for investigation of an experimental therapy.
* Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the Investigator or treating provider.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: From treatment to 12-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Daniel A Tonetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cooper Health System
name: Manisha Koneru, MD
role: STUDY_CHAIR
affiliation: The Cooper Health System
name: Hamza A Shaikh, MD
role: STUDY_CHAIR
References: