A Randomized, Double-blind, Placebo-controlled, Parallel, 12-week, Phase 2a Study of Topical Pirenzepine (WST-057) or Placebo in Type 2 Diabetes Mellitus Patients With Painful Peripheral Neuropathy
Brief description: This is a 12 week, 2-arm, blinded, single-site, placebo-controlled Phase II study in subjects with Type II Diabetes and painful peripheral neuropathy.
Detailed description: This study is designed with 4 periods: screening, baseline/day 0, outpatient treatment, and safety follow-up. Site visits take place At -30 days, -7 days, Day 0, Week 3 (phone assessment), 6, 9 (phone assessment) and 12/end of study [EOS]. There is also a Week 14 phone call for a safety review with the subject. The purpose of this early phase 2 trial is to evaluate the overall safety and tolerability of both the active topical solution and the placebo also called the 'vehicle' formulated as a topical solution that penetrates the skin of the lower legs and tops of the feet. There are also secondary and exploratory objectives to determine if this active has efficacy properties during the 12-week treatment period as hypothesized. Even though pirenzepine is approved and used for another indication systemically, the sponsor believes the active in a topical solution to be effective in treating painful peripheral neuropathy commonly found in diabetic patients. There are both objective and subjective tests being introduced in this trial due to the unique nature of the study, and lack of defined and standardized efficacy parameters.
Detailed description: This study is designed with 4 periods: screening, baseline/day 0, outpatient treatment, and safety follow-up. Site visits take place At -30 days, -7 days, Day 0, Week 3 (phone assessment), 6, 9 (phone assessment) and 12/end of study [EOS]. There is also a Week 14 phone call for a safety review with the subject. The purpose of this early phase 2 trial is to evaluate the overall safety and tolerability of both the active topical solution and the placebo also called the 'vehicle' formulated as a topical solution that penetrates the skin of the lower legs and tops of the feet. There are also secondary and exploratory objectives to determine if this active has efficacy properties during the 12-week treatment period as hypothesized. Even though pirenzepine is approved and used for another indication systemically, the sponsor believes the active in a topical solution to be effective in treating painful peripheral neuropathy commonly found in diabetic patients. There are both objective and subjective tests being introduced in this trial due to the unique nature of the study, and lack of defined and standardized efficacy parameters.