NCT06462781

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Lidocaine hydrochloride	Intra-arterial injection of 40mg lidocaine per middle meningeal artery (total 2 arteries) administered one time
DRUG	Methylprednisolone sodium succinate	Intra-arterial injection of 20mg methylprednisolone per middle meningeal artery (total 2 arteries) administered one time

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-05-13
• Completion: 2025-06-01
• First posted: 2024-06-17
• Last updated: 2025-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study