Lidocaine Patch for Peripheral Neuropathy

(DLss Trial)

Recruiting at 1 trial location

Overseen By Cathy Revere

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Anti-arrhythmics, Chemotherapy

Disqualifiers: Acute neuropathy, Severe liver disease, others

Compensation: Varies

Number of Visits: 5

301 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{1 2 3 4 7}

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.

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

Treatment Details

Interventions

• Diode Laser fiber type Selective Stimulator
• ZTlido 1.8 % Topical System

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study of 31 patients with posttraumatic peripheral neuropathy, the 8% lidocaine pump spray (XPS) significantly reduced pain and tactile allodynia compared to a saline placebo, with effects lasting a median of 5 hours.

XPS was well-tolerated, with only mild local side effects reported, which resolved quickly, highlighting its safety and convenience for managing neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The analgesic effect of a metered-dose 8% lidocaine pump spray in posttraumatic peripheral neuropathy: a pilot study. Kanai, A., Segawa, Y., Okamoto, T., et al.[2013]

In a study of 87 patients with neuropathic and non-neuropathic pain, those with allodynia (sensitivity to touch) experienced significantly greater benefits from topical lidocaine patches, with a tenfold higher likelihood of therapeutic success compared to those without allodynia.

Female patients showed a higher response rate to lidocaine patch treatment (62.5%) compared to males (43.6%), suggesting potential gender-specific effects that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lidocaine patch for therapy of neuropathic and non-neuropathic pain. A clinical case series of 87 patients]. Kern, KU., Kohl, M., Kiefer, RT.[2021]

In a study involving 18 patients, both the lidocaine and piroxicam patches significantly reduced pain intensity in postherpetic neuralgia, but the lidocaine patch was more effective for allodynia and provided faster pain relief.

The piroxicam patch showed particular effectiveness for dull pain and may be a suitable alternative for patients who cannot use the lidocaine patch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of piroxicam patch compared to lidocaine patch for the treatment of postherpetic neuralgia. Kim, JY., Lim, HJ., Lee, WJ., et al.[2021]

In a pilot study involving 16 patients with various refractory peripheral neuropathic pain conditions, 81% reported moderate or better pain relief from using a topical lidocaine patch (Lidoderm) over an average of 6.2 weeks.

The treatment was well-tolerated, with only one patient experiencing mild skin irritation, suggesting that the Lidoderm patch could be a safe option for patients who have not found relief with other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. Devers, A., Galer, BS.[2022]

The 5% lidocaine medicated plaster is effective for treating localized neuropathic pain, particularly in conditions like postherpetic neuralgia and painful diabetic polyneuropathy, showing comparable efficacy to systemic pregabalin.

The lidocaine plaster is generally well tolerated with minimal risk of systemic side effects, making it a safe option for long-term treatment of various neuropathic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical pain management with the 5% lidocaine medicated plaster--a review. Mick, G., Correa-Illanes, G.[2019]

The lidocaine patch has been FDA-approved for treating postherpetic neuralgia and works by blocking sodium channels, which helps reduce pain sensitivity and central nervous system excitability.

Due to its topical application, the lidocaine patch maintains low serum levels even with long-term use, enhancing its safety profile and suggesting potential effectiveness for other chronic neuropathic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New analgesics for neuropathic pain: the lidocaine patch. Argoff, CE.[2019]

In a study involving 16 patients with non-herpetic focal peripheral neuropathic pain, the lidocaine patch 5% significantly reduced mechanical allodynia and showed a near-significant reduction in persistent pain compared to a placebo.

The lidocaine patch was found to be effective and safe, with only mild skin irritations reported, suggesting it can be a beneficial adjuvant treatment for chronic pain in non-herpetic neuropathies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Reduction of chronic pain for non-postherpetic peripheral neuropathies after topical treatment with a lidocaine patch]. Meier, T., Faust, M., Hüppe, M., et al.[2018]

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]

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]

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

Efficacy of piroxicam patch compared to lidocaine patch for the treatment of postherpetic neuralgia. [2021]

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

Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. [2022]

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

Topical pain management with the 5% lidocaine medicated plaster--a review. [2019]

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

New analgesics for neuropathic pain: the lidocaine patch. [2019]

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

[Reduction of chronic pain for non-postherpetic peripheral neuropathies after topical treatment with a lidocaine patch]. [2018]