What side effects are associated with this type of intervention?

Common treatments for peripheral neuropathy, particularly topical applications like capsaicin and lidocaine, are known for their localized side effects. Capsaicin can cause burning, stinging, and redness at the application site, while lidocaine patches may lead to skin reactions such as redness, swelling, and irritation. These side effects are typically mild and confined to the area of application, making topical treatments a preferred choice for many patients due to their reduced systemic absorption and localized action.

What prior FDA approvals exist?

The FDA has approved several treatments for Peripheral Neuropathy, though specific topical applications like ATX01 are less common. One notable topical treatment is the capsaicin 8% patch, which has been approved for neuropathic pain management. Other FDA-approved treatments for neuropathic pain include oral medications such as gabapentin and pregabalin, which are commonly used but have shown limited efficacy in chemotherapy-induced peripheral neuropathy (CIPN). While topical treatments are being explored, most current FDA-approved options are systemic rather than topical.

What other types of research exist?

Promising novel alternatives to ATX01 for peripheral neuropathy patients include: 1) Botulinum toxin type A (BTX-A), which has shown efficacy in reducing pain in diabetic peripheral neuropathy. 2) Duloxetine, which has been demonstrated to be effective in patients with inadequate response to gabapentin. 3) Fulranumab, a monoclonal antibody against nerve growth factor, which has shown potential in early trials. 4) Cannabis-based medicinal products like Sativex, which have shown some efficacy in pain management despite mixed results.

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Topical Analgesic

ATX01 for Chemotherapy-Induced Nerve Pain (ACT Trial)

Phase 2

Waitlist Available

Research Sponsored by AlgoTherapeutix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a skin-applied treatment called ATX01 to help adult cancer survivors who have nerve pain from chemotherapy. The treatment is being evaluated to see if it reduces pain and improves nerve function over a few months.

Who is the study for?

Adults over 18 with painful sensory CIPN from cancer treatment, who've stopped chemotherapy for at least 24 weeks. They must have a BMI of 18-35 kg/m2, life expectancy over 6 months, and pain intensity between 4 and 9 on the NPRS scale. Exclusions include glaucoma, recent heart issues, major depression or psychiatric disorders, pregnancy or lactation, certain ECG abnormalities, use of specific medications including opioids and MAO inhibitors within set timeframes before the trial.

What is being tested?

The trial tests ATX01 cream (10% &15%) against placebo in treating CIPN when applied twice daily for a period of twelve weeks. The goal is to see if ATX01 can reduce neuropathy pain better than a non-active cream.

What are the potential side effects?

While not specified here, topical treatments like ATX01 could cause skin irritation or allergic reactions at the site of application. Systemic side effects are less common but may include dizziness or nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: ATX01 15%Experimental Treatment1 Intervention

A bottle of hydrogel formulation containing 15% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months.

Group II: ATX01 10%Experimental Treatment1 Intervention

A bottle of hydrogel formulation containing 10% amitriptyline hydrochloride w/w for topical use on the hands and/or feet, morning and night for 3 months.

Group III: ATX01 PlaceboPlacebo Group1 Intervention

A bottle of hydrogel formulation containing no active ingredient, for topical use on the hands and/or feet, morning and night for 3 months.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral neuropathy treatments, particularly topical applications like those in the ATX01 trial, work by targeting local pain receptors and reducing inflammation. Agents such as amitriptyline, ketamine, and menthol modulate pain pathways by blocking sodium channels, NMDA receptors, and activating TRPM8 receptors, respectively. This localized approach is important for patients as it can provide effective pain relief with fewer systemic side effects compared to oral medications.

[Peripheral neuropathy rehabilitation. Indications for a diagnostic-rehabilitation approach].