Lidocaine + Steroid Injections for Migraines

(LIGHT 1 Trial)

Overseen By Lynne Kohler

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Cooper Health System

Must not be taking: Nitrates, Antibiotics, Estrogens, others

Disqualifiers: Pregnancy, Intracranial pathology, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those taking certain chronic medications that interact with lidocaine or steroids. It's best to discuss your specific medications with the trial team to see if they might be a concern.

Is the combination of lidocaine and steroids safe for treating migraines?

Lidocaine and steroids like methylprednisolone have been used in various treatments, and studies suggest they are generally safe for short-term use in humans, though the effects may be temporary. However, there are ongoing safety concerns with certain methods of administration, such as intrathecal (injection into the spinal canal) use of methylprednisolone. ^{1 2 3 4 5}

How is the drug Lidocaine + Steroid Injections for Migraines different from other migraine treatments?

This treatment is unique because it involves injecting lidocaine (a local anesthetic) and methylprednisolone (a steroid) directly into specific areas, potentially providing quick relief for migraines by targeting pain trigger points. Unlike standard oral medications, this approach may offer rapid, localized relief for migraines that do not respond well to other treatments. ^{2 3 4 6 7}

What data supports the effectiveness of the drug Lidocaine + Steroid Injections for Migraines?

Research shows that injecting lidocaine and methylprednisolone directly into an artery can help reduce severe headaches for a short time, with effects starting quickly and lasting several hours. Additionally, using lidocaine in the nose has shown to improve migraine symptoms, suggesting it might help when used in other ways too. ^{2 3 8 9 10}

Who Is on the Research Team?

Daniel A Tonetti, MD

Principal Investigator

The Cooper Health System

Manisha Koneru, MD

Principal Investigator

The Cooper Health System

Hamza A Shaikh, MD

Principal Investigator

The Cooper Health System

Are You a Good Fit for This Trial?

This trial is for individuals with chronic headaches or migraines. Participants will receive a one-time treatment involving injections of lidocaine and steroids into brain blood vessels and must attend follow-up appointments at specified intervals while keeping a symptom log.

Inclusion Criteria

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

I have severe migraines and 4 types of preventative drugs haven't worked for me.

Exclusion Criteria

I am not pregnant, breastfeeding, and agree to use birth control during the study.

Blood glucose level on screening complete metabolic blood panel > 400 mg/dL

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time intra-arterial injection of lidocaine and glucocorticoid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person) at 1 week, 6 weeks, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine hydrochloride
• Methylprednisolone sodium succinate

Trial Overview The study tests the safety and effectiveness of injecting lidocaine, a numbing medication, combined with methylprednisolone, an anti-inflammatory steroid, directly into the middle meningeal arteries compared to standard headache care.

How Is the Trial Designed?

Group I: Treatment Cohort Experimental Treatment 2 Interventions

Intra-arterial 80mg lidocaine and 40mg methylprednisolone

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials

82

Recruited

35,600+

Society of Vascular and Interventional Neurology

Collaborator

Trials

2

Recruited

17,900+

Published Research Related to This Trial

In a study of 26 children and adolescents with status migraine, intravenous (IV) lidocaine was found to be a safe and effective treatment, with 90.3% of patients experiencing pain resolution.

On average, patients saw a significant reduction in pain scores within 16.3 hours, and the treatment was well-tolerated, with only one patient experiencing side effects that required interruption of the infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of IV Lidocaine in the Treatment of Children and Adolescents With Status Migraine. Ayulo, MA., Phillips, KE., Tripathi, S.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effect of intra-arterial injection of lidocaine and methyl-prednisolone into middle meningeal artery on intractable headaches. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Is intravenous lidocaine clinically effective in acute migraine? [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of intravenous sodium valproate vs dexamethasone on acute migraine headache: a double blind randomized clinical trial. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Parenteral dexamethasone for acute severe migraine headache: meta-analysis of randomised controlled trials for preventing recurrence. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Rapid and sustained relief of migraine attacks with intranasal lidocaine: preliminary findings. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of IV Lidocaine in the Treatment of Children and Adolescents With Status Migraine. [2019]

7. England pubmed.ncbi.nlm.nih.gov

No beneficial effect of intrathecal methylprednisolone acetate in postherpetic neuralgia patients. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Intranasal lidocaine for acute migraine: A protocol for the systematic review of randomized clinical trials. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The treatment of pain trigger areas in migraine. [2018]

10. Turkey pubmed.ncbi.nlm.nih.gov

[Greater occipital nerve blockade: trigeminicervical system and clinical applications in primary headaches]. [2008]