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

Phase 2

Waitlist Available

Research Sponsored by WinSanTor, Inc

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 12 weeks

Summary

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.

Eligible Conditions

Diabetes
Diabetic Neuropathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment Emergent Adverse Events as assessed by ECG (measuring p wave, QRS complex, QT interval)

Incidence of Treatment Emergent Adverse Events as assessed by dermal assessment (Draize score 0.0-4.0) score of skin erythema, edema pruritus and dryness score) of the dosing area

Incidence of Treatment Emergent Adverse Events as assessed by hematology and clinical pathology blood tests

+1 more

Secondary study objectives

Neuropathy Total Symptom Score-6 (NTSS-6)

Norfolk Quality of Life- Diabetic Peripheral Neuropathy (Norfolk-QOL-DN)

Utah Early Neuropathy Score (UENS)

+2 more

Other study objectives

Intraepidermal Nerve Fiber Density (IENFD) of the dosing area

Norfolk Quality of Life for Diabetic Peripheral Neuropathy -Physical Large Fiber Function Subset Score

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: WST-057 active: 4 mL of WST-057 (4%; 146 mg of pirenzepine free base monohydrate) topical solutionExperimental Treatment1 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 Group2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution

2020

Completed Phase 2

~60

Do I qualify?Apply below to find out