Topical Cream for Peripheral Neuropathy

Not currently recruiting at 7 trial locations

Overseen By Angela Hansen

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: WinSanTor, Inc

Must be taking: Carboplatin, Paclitaxel

Must not be taking: Pain medications, Vitamin E

Disqualifiers: Peripheral neuropathy, Severe paclitaxel hypersensitivity, Macrovascular disease, 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: Unknown

Duration: 19-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a topical cream to determine its effectiveness in alleviating peripheral neuropathy (nerve damage) caused by chemotherapy. Participants will apply either the active cream, containing topical pirenzepine, or a placebo to assess its impact on symptoms like pain, tingling, and numbness. It targets individuals with advanced or metastatic solid tumors who are about to begin chemotherapy with carboplatin and paclitaxel. Those who have experienced nerve issues solely from past chemotherapy may find this trial suitable. As a Phase 2 trial, the research focuses on evaluating 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 stop taking regular pain medications like gabapentin, pregabalin, amitriptyline, or duloxetine, unless they are opioids for short-term malignant pain. Also, you cannot use local anesthetics or analgesics like lidocaine or capsaicin.

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

Research shows that topical pirenzepine has been studied for its safety and tolerability. In past studies, most participants tolerated the treatment well, and no major safety issues were reported. Some studies suggest it can help regrow damaged peripheral nerves, offering promise for those with nerve pain.

However, like any treatment, side effects can occur. In clinical trials, some participants experienced mild reactions like skin irritation, which were not serious and resolved on their own.

For those considering joining a trial, it's important to know that the treatment has undergone previous testing. Ongoing research aims to further understand its safety and effectiveness. Always consult a healthcare professional if there are any concerns. ^{1 2 3 4 5}

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

Researchers are excited about the potential of Topical Pirenzepine for treating peripheral neuropathy because it offers a new way to tackle this condition. Unlike most current treatments, which often involve oral medications like gabapentin or pregabalin, Topical Pirenzepine is applied directly to the skin. This localized approach can potentially reduce systemic side effects while directly addressing nerve pain. Additionally, Pirenzepine works by modulating acetylcholine receptors, offering a unique mechanism of action compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for peripheral neuropathy?

Research has shown that pirenzepine cream might help treat peripheral neuropathy. In this trial, participants will receive either a topical solution of pirenzepine (WST-057 Active) or a placebo. Pirenzepine can promote nerve regeneration and may also prevent further nerve damage. Early results suggest that this treatment could significantly improve nerve health. These findings offer hope to those dealing with peripheral neuropathy. ^{1 4 5 6 7}

Who Is on the Research Team?

Angela Hansen

Principal Investigator

WinSanTor, Inc

Are You a Good Fit for This Trial?

Adults over 18 with advanced solid tumors undergoing chemotherapy (carboplatin and paclitaxel) can join. They must be able to fill out questionnaires, have a life expectancy of at least 6 months, an ECOG status of 0-2, and use effective contraception. Excluded are those with pre-existing neuropathy not from chemo, certain health conditions or treatments that could interfere with the study.

Inclusion Criteria

I am over 18 years old.

Ability to complete patient reported outcome questionnaires by themselves

Ability to sign informed consent and understand the nature of a placebo-controlled trial

Exclusion Criteria

History of sensitive skin

I have nerve damage not caused by previous chemotherapy.

I have problems emptying my bladder or an enlarged prostate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive once-daily topical WST-057 or placebo for up to 19 weeks, or up to 24 weeks if there is a chemotherapy dose delay, alongside 6 cycles of Carboplatin and Paclitaxel

19-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Topical Pirenzepine

Trial Overview The trial is testing WST-057, a topical treatment for chemotherapy-induced peripheral neuropathy against a placebo. Participants will apply it daily while receiving six cycles of carboplatin and paclitaxel chemotherapy over up to 24 weeks in this randomized, double-blind study.

How Is the Trial Designed?

Group I: WST-057 Active Experimental Treatment 1 Intervention

Participants will apply 4 mL QD WST-057 Active topical solution.

Group II: Placebo Experimental Treatment 1 Intervention

Participants will apply 4 mL QD Placebo topical solution

Who Is Running the Clinical Trial?

WinSanTor, Inc

Lead Sponsor

Trials

4

Recruited

190+

Published Research Related to This Trial

The FDA has only approved one new drug, a topical capsaicin patch, for painful diabetic neuropathy in the last decade, while gabapentinoids and SNRIs remain the preferred treatments due to their better safety and efficacy profiles.

Recent literature highlights the importance of exercise as a complementary therapy, which not only helps manage pain but may also improve the underlying conditions associated with polyneuropathy, such as obesity and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Neuropathic Pain in Polyneuropathy. Peltier, AC., Wood, D.[2021]

In a study involving 2177 patients with various chronic pain conditions, two compounded topical creams (Cream I and Cream II) significantly reduced pain intensity scores by 37% and 35%, respectively, compared to a 19% reduction with Voltaren gel.

Both Cream I and Cream II were found to be more effective than Voltaren gel, suggesting that compounded topical formulations may offer better pain relief options for patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Evaluation on the Analgesic Activities of 2 Compounded Topical Creams and Voltaren Gel in Chronic Noncancer Pain. Somberg, JC., Molnar, J.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04005287

A 24-Week Study of Topical Pirenzepine or Placebo in ... This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the safety, tolerability, and exploratory efficacy of topically ...

2. reports.mountsinai.org reports.mountsinai.org/article/neuro2022-07-peripheral-neuropathy-in-diabetes-robinson-papp-and-george

Clinical Trials To Study Two Agents For Painful Peripheral ... The primary outcome is pain, but a secondary outcome is treatment of the underlying disease process. “There are preliminary data for this therapeutic agent that ...

3. pfsfoundation.org pfsfoundation.org/news/biotech-firm-with-promising-treatment-for-peripheral-nerve-damage-soliciting-input-from-pfs-patients/

Biotech Firm with Promising Treatment for Peripheral ... Over the past decade, the WinSanTor team has demonstrated that topically administered pirenzepine can regrow peripheral nerves damaged by ...

4. reporter.nih.gov reporter.nih.gov/project-details/10161766

Clinical Studies - NIH RePORTER Proof of concept clinical data obtained via R21 funding demonstrates that topical treatment with a muscarinic receptor antagonist can significantly reverse loss ...

5. winsantor.com winsantor.com/pipeline

Our Drug Pipeline Our lead compound, WST-057, shows the ability to prevent nerve damage and regrow damaged nerves. Phase 1 and Phase 2 are now complete. Topical ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04005287?cond=%22Peripheral%20Nervous%20System%20Disease%22&intr=%22Anti-Ulcer%20Agents%22&viewType=Table&rank=2

A 24-Week Study of Topical Pirenzepine or Placebo in ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. ctv.veeva.com ctv.veeva.com/study/a-12-week-study-of-topical-pirenzepine-or-placebo-in-type-2-diabetic-patients-t2dm-with-painful-pe

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 ... This is a 12 week, 2-arm, blinded, single-site, placebo-controlled Phase II study in subjects with Type II Diabetes and painful peripheral neuropathy.