Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1

NCT ID: NCT06462781

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-06-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Cohort

Intra-arterial 80mg lidocaine and 40mg methylprednisolone

Group Type: EXPERIMENTAL

Lidocaine hydrochloride

Intervention Type: DRUG

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

Methylprednisolone sodium succinate

Intervention Type: DRUG

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

Interventions

Lidocaine hydrochloride

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

Intervention Type: DRUG

Methylprednisolone sodium succinate

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

Intervention Type: DRUG

Other Intervention Names

lidocaine; Xylocaine-MPF; methylprednisolone; SOLU-MEDROL

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 > 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Society of Vascular and Interventional Neurology

UNKNOWN

Sponsor Role: collaborator

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Daniel A Tonetti, MD

Director, Cerebrovascular Neurosurgery; Director, Acute Stroke and NeuroInterventional Suite

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel A Tonetti, MD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Health System

Manisha Koneru, MD

Role: STUDY_CHAIR

The Cooper Health System

Hamza A Shaikh, MD

Role: STUDY_CHAIR

The Cooper Health System

Locations

Cooper University Health Care

Camden, New Jersey, United States

Countries

United States

References

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

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

23-267

Identifier Type: -

Identifier Source: org_study_id