Lidocaine Infusion for Migraine

Overseen By Jeffrey Katz, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwell Health

Must not be taking: Antiarrhythmics, Anti-nausea, Anti-emetics

Disqualifiers: Allergy to lidocaine, Stroke, Renal insufficiency, Abnormal ECG, 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: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment to help people with chronic migraines who haven't found relief with other medications. The treatment involves infusing lidocaine, a numbing agent, into the blood vessels in the skull to reduce migraine pain, intensity, and frequency. People who have experienced chronic migraines for over a year, with more than 15 headache days per month, and have tried at least three preventive treatments without success, may be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stay on your current headache preventive medication for at least 3 months before screening. However, if you are taking antiarrhythmic medications (other than a beta blocker) or medications that may prolong the QT interval, you may need to stop those.

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

Research has shown that lidocaine infusions are generally well-tolerated for treating headaches and migraines. One study used longer infusions of lidocaine, lasting up to 8.5 days, for chronic daily headaches and reported positive results. Another study focused on children and teens with severe migraines and found lidocaine to be safe and effective for them.

In a different method, lidocaine was infused directly into certain blood vessels in the skull, reducing headache intensity during another procedure. This suggests potential usefulness for treating migraines. Additionally, lidocaine infusions proved safer than another treatment, with patients spending less time in the hospital.

These findings indicate that lidocaine is generally safe for treating migraines, although individual experiences may vary. ^{1 2 3 4 5}

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

Lidocaine infusion is unique for treating migraines because it offers a new approach by using an anesthetic typically applied for numbing during procedures. Unlike standard migraine treatments, which often include oral medications like triptans and anti-inflammatory drugs, lidocaine is administered intravenously, potentially providing faster relief by directly acting on the central nervous system. Researchers are excited because lidocaine might offer quick and effective pain relief for patients who haven't responded well to existing options, addressing a significant gap in migraine management.

What evidence suggests that lidocaine infusion might be an effective treatment for chronic migraine?

Research has shown that lidocaine infusions can greatly reduce headache pain. In one study, patients who received lidocaine experienced quick pain relief, with many becoming pain-free in just under 12 hours on average. Another study found that injecting lidocaine directly into a specific artery in the head provided immediate headache relief that lasted beyond the initial treatment. Additionally, patients with chronic migraines experienced significant pain reduction from the start of treatment to hospital discharge after receiving lidocaine. These findings suggest that lidocaine, which participants in this trial will receive, could be a promising option for relieving chronic migraine symptoms. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-75 with chronic daily headaches (15+ days a month) for at least 3 months, unresponsive to ≥3 treatments, and severe disability from migraines. Must not have allergies to lidocaine or iodinated contrast dye, recent serious heart issues, major psychiatric disorders, drug abuse history within the last year, or be pregnant without contraception.

Inclusion Criteria

Must have demonstrated >75% compliance with diary data for the 28 day duration period

Must continue to meet eligibility criteria when reassessed at baseline completion visit

My current preventive treatment isn't working or causes side effects.

Exclusion Criteria

Known allergy or sensitivity to lidocaine

Severe allergy/anaphylaxis to iodinated contrast dye

Any intracranial pathology on brain imaging within the past 12 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intra-arterial bilateral lidocaine infusion into the middle meningeal artery to treat chronic migraines

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine

Trial Overview The trial tests a new migraine treatment involving targeted lidocaine infusion into skull blood vessels to numb pain receptors. It aims to reduce chronic migraine symptoms' intensity, frequency, and duration in patients who haven't responded well to other treatments.

How Is the Trial Designed?

Group I: Lidocaine Experimental Treatment 2 Interventions

All patients who meet eligilibity criteria at their baseline visit will be scheduled for the Lidocaine procedure.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10448809/

A single infusion of intravenous lidocaine for primary ... A single infusion of IV lidocaine might be an effective and safe transitional treatment in refractory headache conditions with facial pain and trigeminal ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07061847

Bilateral Middle Meningeal Artery Lidocaine Infusion for ... During the intra-arterial infusion of lidocaine for treatment of a subdural procedure, an incidental finding noted that patients had reduced headache intensity ...

3. jnis.bmj.com jnis.bmj.com/content/17/Suppl_1/A20.1

O-021 Effectiveness of repeated middle meningeal artery ... Preliminary data have indicated that lidocaine infusions into the middle meningeal artery (MMAL) can produce immediate headache relief which may persist for ...

4. publications.aap.org publications.aap.org/hospitalpediatrics/article/14/7/541/197488/Effectiveness-of-Lidocaine-Infusion-Versus

Effectiveness of Lidocaine Infusion Versus Valproate ... Patients in the lidocaine group achieved significantly faster control of pain with median hours to pain free of 11.7 (interquartile range, 3.8– ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35609890/

Lidocaine infusions for refractory chronic migraine The primary outcome was change in headache pain from baseline to hospital discharge. Secondary outcomes measured at the post-discharge office visit (25-65 days ...

6. journals.lww.com journals.lww.com/ccmjournal/fulltext/2018/01001/813__safety_and_efficacy_of_intravenous_lidocaine.772.aspx

safety and efficacy of intravenous lidocaine in the treatment ... The objective of this study is to evaluate the safety and efficacy of IV lidocaine in treating children and adolescents with status migraine.

7. ahajournals.org ahajournals.org/doi/10.1161/SVIN.04.suppl_1.322?doi=10.1161/SVIN.04.suppl_1.322

Abstract 322: Localized Injection Of Lidocaine And ... Endovascular injection of lidocaine and methylprednisolone demonstrates potential to be a safe approach to refractory migraine treatments.