Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment

Phase 2

Not yet recruiting

• Conditions: Refractory Migraine
• Interventions: Other: Standard of Care; Drug: Lidocaine hydrochloride; Drug: Methylprednisolone sodium succinate

• Registration Number: NCT06462781
• Lead Sponsor: The Cooper Health System

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 are:

* Is this treatment safe for chronic migraine patients?

* Is this treatment effective for chronic migraine patients?

Participants will:
...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Study Start: 2025-03
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 230

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Cohort	Methylprednisolone sodium succinate	Intra-arterial 80mg lidocaine and 40mg methylprednisolone
Observational Cohort	Standard of Care	Continuation of standard therapies
Treatment Cohort	Lidocaine hydrochloride	Intra-arterial 80mg lidocaine and 40mg methylprednisolone

Primary Outcome Measures

Name	Time	Method
Rate and Duration of Symptomatic Relief	From screening enrollment to the end of study follow-up at 12 weeks	Change in headache assessment scores (MIDAS, verbal pain scale, numeric pain scale) and patient-reported quantitative and qualitative headache symptoms

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	From screening enrollment to the end of study follow-up at 12 weeks	Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event

Trial Locations

Locations (1)

Cooper University Health Care; 🇺🇸 Camden, New Jersey, United States