Lidocaine Patch for Peripheral Neuropathy

(DLss Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Must not be taking: Anti-arrhythmics, Chemotherapy

Disqualifiers: Acute neuropathy, Severe liver disease, others

Trial Summary

What is the purpose of this trial?

The R61 will perform a four-part double-blind randomized crossover study transitioning from a pretreatment baseline phase, to randomized treatment with either lidocaine or an identical placebo patch, washout, and alternate arm. DLss measures will be obtained before and after each phase. Twice daily report of pain using a visual analogue scale will track severity of ongoing spontaneous pain in participants. The hybrid biomarker will distinguish between placebo and active treatment arms, will significantly correlate with extent of neuropathic pain reduction during lidocaine, but will not change during the placebo phase or no-treatment lead-in. If preset Go/No-Go criteria are met, the subsequent R33 validation will then compare lidocaine patch and placebo treatment in a blinded, randomized parallel arm study.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications related to lidocaine or with anti-arrhythmic properties, like tocainide or mexilitine. If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment for peripheral neuropathy?

Research shows that lidocaine patches are effective in reducing pain for various types of nerve pain, including postherpetic neuralgia and other peripheral neuropathic pain conditions.

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Is the lidocaine patch safe for treating peripheral neuropathy?

The lidocaine patch is generally considered safe for treating neuropathic pain, as it results in low levels of the drug in the bloodstream even with long-term use, which enhances its safety profile.

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How is the lidocaine patch treatment unique for peripheral neuropathy?

The lidocaine patch is unique because it provides localized pain relief directly to the affected area, which can be more effective for certain types of neuropathic pain compared to systemic treatments. It is particularly useful for conditions like postherpetic neuralgia and other focal neuropathies, offering a non-invasive and targeted approach.

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Eligibility Criteria

This trial is for adults with peripheral neuropathy or neuralgia from non-acute causes like diabetes, pre-diabetes, or injury. Participants must be aged 18-70 and not have a medical history of conditions or medications that cause neuropathy. They can't join if they're allergic to lidocaine, currently on chemotherapy, taking certain heart drugs, have acute neuropathy issues like Guillain-Barre Syndrome, severe liver disease, or bleeding problems.

Inclusion Criteria

I do not have foot pain or numbness.

I am between 18 and 70 years old.

I am 18 or older with long-term nerve pain or pain from plantar fasciitis or an ankle sprain.

Exclusion Criteria

You have a known allergy to lidocaine or similar types of numbing medication.

I do not have acute peripheral neuropathy like Guillain-Barre Syndrome.

I am not taking medications like lidocaine or those for irregular heartbeat.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline

Baseline neuropathic pain evaluation and daily pain severity recording

1 week

1 visit (in-person)

Treatment Period 1

Randomized treatment with either lidocaine or placebo patch

1 week

1 visit (in-person)

Washout

7-day washout period without treatment

1 week

1 visit (in-person)

Treatment Period 2

Daily treatment with the alternate patch not received in the first treatment period

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests the effectiveness of a lidocaine patch versus a placebo in reducing pain for those with peripheral neuropathy. It's a double-blind crossover study where participants switch between treatments. Pain levels are tracked daily using visual scales and special equipment measures changes before and after each phase.

Group I: Neuropathy assessment and biomarker testing (Utah) Experimental Treatment 3 Interventions

History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging

Group II: Biomarker Optimization (Stanford) Experimental Treatment 3 Interventions

Screening for neuropathy, foot problems and diabetes Diode laser testing of C:Aδ ratio Non-invasive speckle imaging Quantitative sensory testing ZTlido 1.8% lidocaine patch testing in some subjects

Group III: Crossover testing in participants with painful neuropathy (ZTlido 1.8% lidocaine patch) Active Control 4 Interventions

History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging ZTlido 1.8% lidocaine patch application to both feet for 7 days up to 12 hours per day.

Group IV: Crossover testing in participants with painful neuropathy (placebo patch) Placebo Group 4 Interventions

History, physical, and neurological exam Nerve conduction study Medical record review of neuropathy history PROMIS pain severity and interference testing Brief pain inventory Norfolk quality of life questionnaire Quantitative sensory testing 3mm skin punch biopsy Diode laser testing of C:Aδ ratio Non-invasive speckle imaging Placebo patch application to both feet for 7 days up to 12 hours per day.

Diode Laser fiber type Selective Stimulator is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Lidoderm for:

• Postherpetic neuralgia
• Painful diabetic polyneuropathy

🇪🇺 Approved in European Union as Lidocaine for:

• Postherpetic neuralgia
• Other neuropathic pain conditions

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford University Palo Alto, CA

University of Utah Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah Lead Sponsor

Stanford University Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) Collaborator

National Institutes of Health (NIH) Collaborator

References

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

The analgesic effect of a metered-dose 8% lidocaine pump spray in posttraumatic peripheral neuropathy: a pilot study. [2013] A topical lidocaine patch is effective in the treatment of posttraumatic peripheral neuropathy (PTPN), but it is not suited for breakthrough pain because of difficulty with an additional application. Here, we examined the effect of 8% lidocaine pump spray (Xylocaine pump spray, XPS) on peripheral neuropathic pain caused by surgery or injury.

2. Germany pubmed.ncbi.nlm.nih.gov

[Lidocaine patch for therapy of neuropathic and non-neuropathic pain. A clinical case series of 87 patients]. [2021] Topical lidocaine patches (LP) reduce pain in postherpetic neuralgia and other forms of focal neuropathy. The aim of this study was to determine clinical predictors of therapeutic success.

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Efficacy of piroxicam patch compared to lidocaine patch for the treatment of postherpetic neuralgia. [2021] The lidocaine patch has been effectively used as a first-line therapy to treat neuropathic pain such as postherpetic neuralgia (PHN).

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

Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. [2022] Our goal was to perform a pilot study to assess the effectiveness and tolerability of a topical lidocaine patch (Lidoderm) for the treatment of peripheral neuropathic pain conditions other than postherpetic neuralgia.

5. England pubmed.ncbi.nlm.nih.gov

Topical pain management with the 5% lidocaine medicated plaster--a review. [2019] The topical 5% lidocaine medicated plaster is recommended as first-line treatment for localized peripheral neuropathic pain.

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

New analgesics for neuropathic pain: the lidocaine patch. [2019] Despite the availability of different pharmacologic agents for the treatment of various chronic neuropathic pain syndromes, complete symptom reduction and/or complete functional restoration is rarely achieved. New, safe, and effective treatments for chronic neuropathic pain, therefore, must be developed. One such agent, the lidocaine patch (Lidoderm, Endo Pharmaceuticals, Inc., Chadds Ford, PA), has been approved recently by the US Food and Drug Administration for the treatment of postherpetic neuralgia. Like other local anesthetics, the lidocaine patch results in sodium channel blockade, dampening, both peripheral nociceptor sensitization and, ultimately, central nervous system hyperexcitability. The Lidoderm patch is a topical agent and, consequently, insignificant serum levels are achieved even with chronic use. This fact enhances its safety. Recent studies have suggested that the lidocaine patch may be effective for chronic neuropathic pain conditions other than postherpetic neuralgia as well.

7. Germany pubmed.ncbi.nlm.nih.gov

[Reduction of chronic pain for non-postherpetic peripheral neuropathies after topical treatment with a lidocaine patch]. [2018] To clarify whether the therapeutic indication for a lidocaine patch to treat postherpetic neuralgia can be extended to include other focal peripheral neuropathic pain syndromes, we performed a subgroup analysis of a placebo-controlled, double-blind randomized study.