Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1

NCT06462781 | Completed Phase 1 FDA Drug

• 1 other identifier: 23-267
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Migraine

Keywords

headache; migraine; lidocaine; glucocorticoid; middle meningeal artery; intra-arterial; status migrainosus

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event

  From treatment to 12-week follow-up

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

Intra-arterial 80mg lidocaine and 40mg methylprednisolone

Drug: Lidocaine hydrochloride; Drug: Methylprednisolone sodium succinate

Interventions

Lidocaine hydrochloride DRUG

Intra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time

Also known as: lidocaine, Xylocaine-MPF

Treatment Cohort

Methylprednisolone sodium succinate DRUG

Intra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time

Also known as: methylprednisolone, SOLU-MEDROL

Treatment Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \> 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.

Sponsors & Collaborators

• The Cooper Health System: lead
• Society of Vascular and Interventional Neurology: collaborator

Study Sites (1)

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Related Publications (1)

• Koneru M, Shaikh HA, Khalife J, Syrow L, Santucci J, Ballout AA, Patel PD, Thomas AJ, Jovin TG, Tonetti DA. Localized Injection of Lidocaine and Glucocorticoid for Refractory Headache Treatment (LIGHT): A Phase 1 Clinical Trial for Safety. Stroke: Vascular and Interventional Neurology. 2025 Oct 29. https://doi.org/10.1161/SVIN.125.001966

  RESULT

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Lidocaine; Methylprednisolone Hemisuccinate; Methylprednisolone

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Daniel A Tonetti, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

• Manisha Koneru, MD

  The Cooper Health System

  STUDY CHAIR

• Hamza A Shaikh, MD

  The Cooper Health System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cerebrovascular Neurosurgery; Director, Acute Stroke and NeuroInterventional Suite

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: March 15, 2024
• Primary Completion: May 13, 2025
• Study Completion: June 1, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

US (1)