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Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1

Intra-Arterial Injection of Lidocaine and Glucocorticoid in the Treatment of Intractable Headaches: A Non-Randomized, Open-Label Phase 1 Clinical Trial

NCT06462781•The Cooper Health System

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;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.
+5 more criteria

Locations (1)

Cooper University Health Care

Camden, New Jersey, United States

Key Dates

Start Date

March 15, 2024

Primary Completion Date

May 13, 2025

Completion Date

June 1, 2025

Last Updated

November 4, 2025

Enrollment

ACTUAL participants

Conditions

Refractory Migraine

Interventions

Lidocaine hydrochloride

DRUG

Methylprednisolone sodium succinate

DRUG