ORAL ZOPOLRESTAT IN SUBJECTS WITH PERIPHERAL SYMMETRICAL DIABETIC POLYNEUROPATHY

点击翻译按钮获取中文摘要

After an initial screening period of up to 3 weeks, each subjects will enter a single-blind placebo baseline period of approximately 4 weeks duration to perform baseline assessments. The single-blind placebo baseline period will be followed by a double-blind period of 18 months duration during which each subject will be treated with either placebo or zopolrestat. During double-blind therapy, complete neuroelectrophysiology evaluations will be obtained. A baseline sural nerve biopsy will be performed at the week 0 visit after all neuroelectrophysiology evaluations. The final sural nerve biopsy will be performed at week 78. Primary efficacy endpoints are sural nerve fiber density and composite neuroelectrophysiology. Subjects who have completed the entire 78 weeks of therapy without major protocol violations and who have had all final efficacy and safety determinations including hte final sural nerve biopsy will automatically be allowed to enter Protocol 078-107x, a 2 1/2 year extension of the current protocol to collect additional safety and efficacy data on longer-term administration of zopolrestat.