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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with chronic migraines who have not found relief with at least four different preventative medications. The treatment involves injecting lidocaine (a local anesthetic) and steroids into specific blood vessels in the brain to assess its safety and effectiveness for migraines. Participants will receive the treatment once, followed by appointments at 1, 6, and 12 weeks. Ideal candidates for this trial are those with chronic migraines unresponsive to current treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive it.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using lidocaine and steroids together for headaches might be safe. In one study, two patients who received these injections reported less headache pain after 24 hours, suggesting the treatment might help reduce headache intensity.

Another study involved 26 children and teenagers with severe migraines. They received lidocaine through an IV, and 90.3% found it safe and helpful, indicating that lidocaine is generally well-tolerated.

While these findings are promising, the trial remains in an early stage. The treatment's safety in humans is still being carefully monitored, and more information is needed to confirm its safety for treating migraines in this way. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraines?

Unlike standard migraine treatments that often rely on oral medications or preventive therapies like beta-blockers and triptans, this investigational approach combines lidocaine hydrochloride and methylprednisolone sodium succinate in an intra-arterial injection. This method directly targets migraine symptoms with lidocaine's numbing effect, potentially offering faster relief. Additionally, the anti-inflammatory properties of methylprednisolone might help reduce the frequency and severity of migraines, providing a dual-action benefit. Researchers are excited because this combination could offer immediate and longer-lasting relief compared to existing treatments.

What evidence suggests that this treatment might be an effective treatment for migraines?

Research suggests that lidocaine and methylprednisolone might help with migraines by calming nerve activity and reducing swelling. Lidocaine blocks nerve signals that cause pain, while methylprednisolone reduces swelling in the area. In past cases, patients experienced some improvement in headache intensity after these injections. However, the relief was short-lived, with some improvement seen within 24 hours but not complete relief. This trial will investigate the combination of lidocaine and methylprednisolone as a potential new approach to addressing difficult migraines, but more research is needed to confirm its long-term effectiveness. ^{1 2 3 6 7}

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. ahajournals.org ahajournals.org/doi/10.1161/SVIN.125.001966

A Phase 1 Clinical Trial for Safety Lidocaine interferes with aberrant sensory neuron depolarization, and methylprednisolone reduces local inflammation. Thus, it is hypothesized ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07054801

IA Lidocaine and Methylprednisolone for Headache ... The results of this study may provide early evidence to support new treatment options for patients suffering from difficult-to-control headaches after a SAH.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4280869/

Effect of intra-arterial injection of lidocaine and methyl ... The effect of injection of lidocaine and methylprednisolone was short lasting. Both patients reported improvement but not resolution of headache even after 24 h ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06462781

NCT06462781 | Localized Injection of Lidocaine and ... 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 ( ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25566345/

Effect of intra-arterial injection of lidocaine and methyl ... Both patients reported improvement in headache intensity after 24 h post-procedure. Intra-arterial injection of lidocaine and methylprednisolone may represent ...

6. withpower.com withpower.com/trial/phase-2-headache-2-2025-bfec8

Lidocaine + Steroid Injections for Migraines (LIGHT 1 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 ...

7. journals.sagepub.com journals.sagepub.com/doi/10.1177/03331024241269735

International Headache Society Global Practice ... We suggest a combination therapy with two migraine preventive agents in individuals who do not have enough benefit from any single migraine ...