NCT04005287

A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy

A Randomized, Double-Blind, Placebo-Controlled, Parallel, 24-Week, Phase 2a Study of Topical Pirenzepine (WST-057) or Placebo in Type 2 Diabetic Patients With Peripheral Neuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: WinSanTor, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the safety, tolerability, and exploratory efficacy of topically administered WST-057 (4% pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral neuropathy.

Detailed description

This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the safety, tolerability, and exploratory efficacy of topically administered WST-057 (4% pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral neuropathy. Subjects will attend visits at screening (day -45 to -28); day 1 (baseline); weeks 2, 4, 8, 12, 16, 20, 24; and follow-up (week 26). Approximately 60 subjects with T2DM with peripheral neuropathy will be randomized to 1 of 4 treatment groups in a 1:1:4:4 ratio: placebo control 2 mL (n = 6 subjects), placebo control 4 mL (n = 6 subjects); low dose (2 mL) WST-057 (73 mg pirenzepine free base monohydrate) (n = 24 subjects); and high dose (4 mL) WST-057 (146 mg pirenzepine free base monohydrate) (n = 24 subjects), with the assumption that a total of 50 subjects will complete the study. This study is designed with 4 periods: screening, baseline/day 1, outpatient treatment, and safety follow-up.

Conditions

• Peripheral Neuropathy
• Painful Diabetic Neuropathy
• Diabetic Neuropathies, Painful

Interventions

Type	Name	Description
DRUG	WST-057 (4% pirenzepine) Lose Dose 2mL	Topical Solution
DRUG	WST-057 (4% pirenzepine) High Dose 4mL	Topical Solution
DRUG	Placebo Low Dose	Topical Solution
DRUG	Placebo High Dose	Topical Solution

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-12-15
• Completion: 2021-12-15
• First posted: 2019-07-02
• Last updated: 2022-12-16

Locations

5 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study