A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy

Overseen By Carolina Casellini, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: WinSanTor, Inc

Must not be taking: Anticholinergics, Antispasmodics

Disqualifiers: Severe neuropathy, Proliferative retinopathy, Dialysis, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a medicated cream for people with Type II Diabetes who have painful feet and lower legs. The cream contains pirenzepine and is applied to the skin to help reduce pain by acting on nerve pathways.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, you must be on stable diabetic and pain treatments before and during the study, and certain topical pain treatments are not allowed.

What safety data exists for the treatment known as Pirenzepine?

The provided research articles do not contain specific safety data for Pirenzepine or its use in clinical trials. ^{1 2 3 4 5}

How does the drug pirenzepine differ from other treatments for this condition?

Pirenzepine is unique because it selectively targets M1-muscarinic receptors, which allows it to reduce stomach acid secretion at lower doses without significantly affecting other bodily functions like gastrointestinal motility or heart rate. This makes it different from traditional anticholinergic drugs, which often have broader effects and more side effects. ^{6 7 8 9 10}

Research Team

Angela Hansen

Principal Investigator

WinSanTor, Inc

Eligibility Criteria

Inclusion Criteria

Men must use a contraceptive that is accepted by both of us, such as a condom with a diaphragm, a condom with a cervical cap, or a condom with spermicide.

Be able to report accurately and reliably symptoms, including treatment-emergent signs and symptoms.

The individual has had diabetic neuropathy for at least 12 months that has affected their lower extremities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline/Day 0

Initial assessments and baseline measurements are conducted

1 day

1 visit (in-person)

Treatment

Participants receive either the active topical solution or placebo once daily for 12 weeks

12 weeks

4 visits (in-person), 2 visits (phone assessment)

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (phone assessment)

Treatment Details

Interventions

• Pirenzepine

Participant Groups

Group I: WST-057 active: 4 mL of WST-057 (4%; 146 mg of pirenzepine free base monohydrate) topical solution Experimental Treatment 1 Intervention

The WST-057 is the active topical solution and contains pirenzepine free base monohydrate. It is dispensed with a pump to deliver (with 4 pumps) 4 mL to the calves (mid-calf sock line), ankles and the tops of both feet. Both solutions (active and placebo) are applied once-a-day for 12 weeks.

Group II: Placebo: 4 mL of matching placebo topical solution. Placebo Group 2 Interventions

The placebo solution contains the same ingredients as the active solution with the exception of the active WST-057. It is dispensed with a pump to deliver 4 mL to the calves (mid-calf sock line), ankles and the tops of both feet. Both solutions (active and placebo) are applied once-a-day for 12 weeks.

Who Is Running the Clinical Trial?

WinSanTor, Inc

Lead Sponsor

Trials

4

Recruited

190+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Eastern Virginia Medical School

Collaborator

Trials

77

Recruited

16,500+

Findings from Research

In a safety analysis of the CHIMES study involving 1,087 stroke patients, those treated with MLC601 experienced significantly fewer serious adverse events (SAEs) compared to those receiving a placebo, particularly for patients with multiple SAEs (6.7% vs. 29.3%).

Patients on MLC601 also had a significantly lower rate of prolonged hospitalizations, suggesting that MLC601 not only reduces SAEs but may also lessen the overall healthcare burden and associated medical costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study. Venketasubramanian, N., Moorakonda, RB., Lu, Q., et al.[2020]

MetaADEDB 2.0 is an updated online database that now includes 744,709 drug-adverse drug event (ADE) associations, representing a 40% increase from its previous version, making it a more comprehensive resource for researchers.

The new version features a user-friendly web interface, enhancing accessibility for drug safety assessments and studies in drug discovery and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. Yu, Z., Wu, Z., Li, W., et al.[2021]

The SMART Safety dataset is the largest collection of empirical data on adverse events in healthcare, comprising 151 systematic reviews and 629 meta-analyses, which enhances the understanding of safety outcomes in randomized controlled trials.

This dataset, which includes over 2,300 trials and 362 harm outcomes, has been rigorously validated to ensure high data quality, providing a valuable resource for addressing rare adverse events and biases in evidence synthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SMART Safety: An empirical dataset for evidence synthesis of adverse events. Fan, S., Yu, T., Yang, X., et al.[2023]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Frequency and Clinical Impact of Serious Adverse Events on Post-Stroke Recovery with NeuroAiD (MLC601) versus Placebo: The CHInese Medicine Neuroaid Efficacy on Stroke Recovery Study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

MetaADEDB 2.0: a comprehensive database on adverse drug events. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Multi-centre, multi-database studies with common protocols: lessons learnt from the IMI PROTECT project. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The SMART Safety: An empirical dataset for evidence synthesis of adverse events. [2023]

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

The impact of minor adverse event tracking on subject safety: a web-based system. [2009]

6. Poland pubmed.ncbi.nlm.nih.gov

Central action of pirenzepine. [2013]

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

Human cardiac beta1- or beta2-adrenergic receptor stimulation and the negative chronotropic effect of low-dose pirenzepine. [2013]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Pirenzepine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in peptic ulcer disease and other allied diseases. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Automated monoclonal radioimmunoassays for pirenzepine, a selective muscarinic receptor antagonist, in plasma and urine. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Cerebro-spinal fluid concentrations of pirenzepine after therapeutic dosage. [2013]