ORAL ZOPOLRESTAT IN SUBJECTS WITH PERIPHERAL SYMMETRICAL DIABETIC POLYNEUROPATHY

在长达3周的初始筛查期之后，每个受试者将进入为期约4周的单盲安慰剂基准期，以进行基线评估。单盲安慰剂基准期之后将是为期18个月的双盲期，在此期间，每个受试者都将接受安慰剂或佐波利司他的治疗。在双盲治疗期间，将获得完整的神经电生理评估。在所有神经电生理评估后的第0周，将进行基线腓肠神经活检。最后一次腓肠神经活检将在78周进行。主要疗效终点为腓肠神经纤维密度和复合神经电生理。完成了整个78周的治疗而没有严重违反协议，并进行了所有最终疗效和安全性确定，包括最后的腓肠神经活检的受试者将被自动允许进入078-107x方案，这是当前方案的两年半延期，以收集有关长期服用佐波雷司特的额外安全性和有效性数据。

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.