CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
WST-057 (4% pirenzepine) Lose Dose 2mL +3 moredrug
Likely dose
WST-057 (4% pirenzepine) Lose Dose 2mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04005287
NCT04005287Phase 2Completed
CompareCT.gov

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

WinSanTor, Inc·interventional·Posted Jul 2, 2019·Updated Dec 16, 2022

In Brief

A Phase 2 clinical trial evaluating WST-057 (4% pirenzepine) Lose Dose 2mL, WST-057 (4% pirenzepine) High Dose 4mL, and 2 other interventions for Peripheral Neuropathy and 2 related conditions. Completed, enrolled 58 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Neuropathy, Painful Diabetic Neuropathy, Diabetic Neuropathies, Painful
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 2, 2019
Enrollment StartOct 15, 2019
Primary CompletionDec 15, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7 years ago

Interventions

WST-057 (4% pirenzepine) Lose Dose 2mLdrug

Topical Solution

WST-057 (4% pirenzepine) High Dose 4mLdrug

Topical Solution

Placebo Low Dosedrug

Topical Solution

Placebo High Dosedrug

Topical Solution