Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment

Refractory Migraine Clinical Trial

— LIGHT  

Official title:

Intra-Arterial Injection of Lidocaine and Glucocorticoid in the Treatment of Intractable Headaches

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462781
• Other study ID #: 23-267
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2025
• Est. completion date: March 2027

Study information

• Verified date: June 2024
• Source: The Cooper Health System
• Contact: Lynne Kohler
• Phone: 855-306-3876
• Email: kohler-lynne[@]cooperhealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 are:

• Is this treatment safe for chronic migraine patients?

• Is this treatment effective 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Refractory Migraine

Intervention

Drug:
• Lidocaine hydrochloride
Intra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time
• Methylprednisolone sodium succinate
Intra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time

Other:
• Standard of Care
Acute and/or preventative therapeutic approaches currently used in practice

Locations

Country	Name	City	State
United States	Cooper University Health Care	Camden	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and Duration of Symptomatic Relief	Change in headache assessment scores (MIDAS, verbal pain scale, numeric pain scale) and patient-reported quantitative and qualitative headache symptoms	From screening enrollment to the end of study follow-up at 12 weeks
Secondary	Number of Participants with Adverse Events	Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event	From screening enrollment to the end of study follow-up at 12 weeks