Pirenzepine for Neuropathy

No longer recruiting at 2 trial locations

Overseen By Daniel Vincent, M.Sc.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: WinSanTor, Inc

Must be taking: Antiretrovirals

Must not be taking: Anticholinergics, Antispasmodics

Disqualifiers: Diabetes, Hepatitis C, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a topical treatment called WST-057 to determine its effectiveness in reducing symptoms of HIV-associated distal sensory polyneuropathy, which causes pain or numbness, usually in the feet. The study aims to assess the safety and effectiveness of this new treatment. Participants will receive either WST-057 or a placebo (a substance with no active treatment) for 16 weeks. Individuals with HIV who manage their symptoms with antiretroviral therapy and experience nerve-related issues in their feet might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are diabetic, you must be on stable antidiabetic treatment, and any non-drug pain treatments should remain stable. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that WST-057 is likely to be safe for humans?

Research has shown that WST-057, a cream applied to the skin, was tested for safety in earlier studies. These studies evaluated daily use of WST-057 and monitored factors like heart rate and blood pressure to identify potential issues. So far, no major safety concerns have emerged.

In previous trials, participants used varying amounts of WST-057. The results indicated that most handled the treatment well, experiencing no serious side effects. However, individual reactions to treatments can vary.

WST-057 remains under investigation. Researchers continue to gather information on its safety and effectiveness. As the study progresses, additional data will help confirm WST-057's safety for treating HIV-related nerve pain. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for HIV-associated distal sensory polyneuropathy, which often involves pain management medications like gabapentin or antidepressants, WST-057 is a topical solution that offers a unique approach. Researchers are excited about WST-057 because it leverages a new active ingredient, pirenzepine, which is thought to target nerve pain differently by potentially reducing inflammation directly at the site of application. This localized delivery method could minimize systemic side effects, offering a safer alternative to oral medications. Additionally, if effective, WST-057 might provide relief more quickly and efficiently compared to existing oral treatments.

What evidence suggests that WST-057 might be an effective treatment for sensory polyneuropathy in HIV?

Research shows that WST-057, a treatment in this trial, may help treat nerve pain when applied to the skin. Early studies suggest it could effectively manage pain and might even address underlying causes, particularly in conditions like HIV-related nerve damage. The treatment does not enter the brain, which enhances safety. Initial results indicate it is safe and well-tolerated, with no major side effects reported. Although more research is needed, early signs are promising for reducing pain from nerve damage. Participants in this trial may receive either WST-057 or a placebo. ^{1 2 3 6 7}

Who Is on the Research Team?

Angela Hansen

Principal Investigator

WinSanTor, Inc

Are You a Good Fit for This Trial?

Inclusion Criteria

Females should be either not of childbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential and must be practicing a highly effective medically acceptable method of contraception, including abstinence; hormonal contraceptives (e.g., combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device or intrauterine system; or vasectomy (partner), for at least 1 month before the screening visit and for 1 month after the end of the last dose of study drug. If access or use of a highly effective medically acceptable method of contraception is not achievable, then a combination of barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge) is acceptable. Eligible female subjects must also have a negative serum beta-human chorionic gonadotropin at the screening visit.

Return for study visits on the required dates

Prior week VAS for average pain/discomfort (altered sensation) and/or altered sensations on lower extremities > 20 mm and < 80mm (0 mm = no pain-100 mm = very severe pain) at screening.

Exclusion Criteria

You have skin or soft-tissue lesions on your calves, ankles, or tops of feet that are painful or could affect feeling.

Any open wound(s) and/or sunburn(s) in the dosing area. Subjects who have a wound and/or sunburn at screening that is anticipated to resolve before day -1 can be enrolled.

You have not taken any new or experimental drugs, biologics, or medical devices in the past 3 months before screening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Baseline assessments and stratification based on pain scores using the Visual Analog Scale (VAS)

1 day

1 visit (in-person)

Treatment

Participants receive daily topical dosing of WST-057 or placebo for 16 weeks

16 weeks

Visits at Day 0, Weeks 4, 8, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person) at Week 18

What Are the Treatments Tested in This Trial?

Interventions

• WST-057

How Is the Trial Designed?

Group I: WST-057 Experimental Treatment 1 Intervention

WST-057 topical solution

Group II: Placebo Placebo Group 2 Interventions

WST-057 Matching placebo

Who Is Running the Clinical Trial?

WinSanTor, Inc

Lead Sponsor

Trials

4

Recruited

190+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05488873

NCT05488873 | A Study of Topical Pirenzepine or Placebo ... This is a randomized, double-blind, placebo-controlled adaptive study of the safety, tolerability, and exploratory efficacy of once-daily topical WST-057 ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT04005287

A 24-Week Study of Topical Pirenzepine or Placebo in ... Dermal safety will be assessed by observing changes in dermal scores (from baseline) in patients after daily dosing of either 2 dose levels of WST-057 solution ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03939

A Study of Topical Pirenzepine or Placebo in Oncology ... This is a randomized, double-blind, placebo-controlled adaptive study of the safety, tolerability, and exploratory efficacy of once-daily topical WST-057

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

Clinical Studies - NIH RePORTER The clinical data obtained from this project suggest that WST-057 is safe (as evidenced by the fact that it does not cross the blood-brain barrier, has no ...

6. sec.gov sec.gov/Archives/edgar/data/1611161/000167025425000404/document_2.pdf

WINSANTOR WST-057: A Novel &. Proprietary MOA. Massive Opportunity and. Expansion Potentiality. SYMPTOMS. Peripheral nerve endings. Hot. Cold. Normal skin ...

7. withpower.com withpower.com/trial/phase-3-pain-10-2020-7393a

A 12-Week Study of Topical Pirenzepine or Placebo in ... The provided research articles do not contain specific safety data for Pirenzepine or its use in clinical trials. ... The WST-057 is the active topical solution ...