Lidocaine + Methylprednisolone for Headache

(LIMSAH Trial)

Overseen By Daniel Raper, MBBS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Disqualifiers: Migraines, Severe renal impairment, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether two medications, lidocaine and methylprednisolone, can reduce severe headaches in patients who recently experienced a subarachnoid hemorrhage (a type of brain bleed). These medications are administered directly into a brain blood vessel during a routine imaging test. The goal is to determine if this treatment can safely lessen headache pain and reduce the need for opioid painkillers, which often have unwanted side effects. Suitable participants have experienced these severe headaches after a brain bleed and are already scheduled for a specific brain imaging procedure. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that using lidocaine and methylprednisolone together may help treat headaches. In some studies, participants who received these medications felt better, though not completely pain-free, within 24 hours.

This combination has been used in nerve blocks for headaches. Approximately 26% of participants reported significant improvement, and 49% noticed some improvement. This suggests the treatment can be quite helpful and is generally well-tolerated.

Regarding safety, the focus is on how the treatment affects the body when injected directly into arteries. This trial is in an early stage (Phase 2), which means it is still testing the method's safety for patients. While detailed safety data is not yet available, the progression to this phase indicates that the drugs have shown enough safety promise to continue in trials. ^{1 2 3 4 5}

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

Researchers are excited about the combination of lidocaine and methylprednisolone for treating headaches because it introduces a unique delivery method and mechanism. Unlike standard headache treatments like oral pain relievers or traditional corticosteroids, this combination is administered intra-arterially, which could allow for faster and more targeted relief. Lidocaine acts as a local anesthetic that may help in numbing the pain quickly, while methylprednisolone, a potent anti-inflammatory, works to reduce inflammation at the source of the headache. This dual-action approach could offer more immediate and effective relief compared to current options.

What evidence suggests that this treatment might be an effective treatment for headaches after SAH?

Research has shown that lidocaine and methylprednisolone can help with tough headaches. Lidocaine blocks unusual nerve signals that cause pain, while methylprednisolone reduces swelling. In past studies, patients experienced some headache relief after using these medications, but the relief was short-lived. One study found that lidocaine helped nearly 88% of people with chronic migraines feel less pain during their hospital stay. This trial will evaluate the combination of lidocaine and methylprednisolone to determine if it can ease headaches for those suffering after a brain bleed. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel Raper, MBBS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for patients who have recently suffered a subarachnoid hemorrhage (SAH) and are experiencing persistent severe headaches. Participants must be undergoing a routine cerebral angiogram, which will be used to administer the treatment.

Inclusion Criteria

Willingness to comply with study procedures and follow-ups

I am over 18 and have had a stroke confirmed by CT or MRI.

I am scheduled for or have had a DSA (Digital Subtraction Angiography) as part of my care.

Exclusion Criteria

My liver is severely damaged.

Known allergy or hypersensitivity to lidocaine or amide-type anesthetics

Severe comorbid conditions with life expectancy <30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Intra-arterial administration of lidocaine and methylprednisolone via the middle meningeal artery during routine angiogram

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in headache severity, opioid use, and neurological outcomes

12 weeks

Visits at discharge, 1, 6, and 12 weeks post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine
• Methylprednisolone

Trial Overview The study tests if injecting lidocaine and methylprednisolone directly into an artery in the brain can reduce headache severity after SAH. The procedure is minimally invasive, performed during an angiogram, aiming to lower pain and opioid use.

How Is the Trial Designed?

Group I: Treatment Cohort Experimental Treatment 2 Interventions

Intra-arterial 80 mg lidocaine and 40 mg methylprednisolone

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. 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 ...

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. 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 ...

4. medicalnewstoday.com medicalnewstoday.com/articles/chronic-migraine-common-anesthetic-relieves-pain-in-new-study

Chronic migraine: Common anesthetic could provide relief Nearly 88% of chronic migraine patients receiving intravenous lidocaine during hospitalization showed a reduction in pain intensity at discharge ...

5. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14841

The effectiveness of parenteral agents to mitigate relapses ... To compare the effectiveness of parenteral agents to reduce relapse in patients with acute migraine and identify factors that predict relapse.

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/81/NCT06462781/Prot_SAP_000.pdf

Study Protocol with Statistical Analysis Plan Brief Title Primary outcome is safety of the lidocaine and methylprednisolone co-administration intra-arterially into the middle meningeal arteries.

7. researchgate.net researchgate.net/publication/382131257_Efficacy_and_safety_of_greater_occipital_nerve_block_with_a_small_volume_of_lidocaine_and_methylprednisolone_in_tertiary_headache_center

(PDF) Efficacy and safety of greater occipital nerve block ... For headache intensity, 26% reported substantial and 49% partial improvement. Migraine patients experienced a significant reduction in median monthly headache ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923002507

Review article Nerve Blocks in the Treatment of Headache Long-lasting relief was seen in 26 of 54 migraine patients who received a unilateral GON block with lidocaine and methylprednisolone. GON blockade seems ...