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12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study (DE-DPN)

2018年9月26日 更新者：NeuromaxBionevia

Twelve-Month Chronic Efficacy and Safety of Diepalrestat in Adult Subjects With Diabetic Peripheral Neuropathy (DPN), A Randomized, Double-Blind, Placebo-Controlled Study

An interventional study to investigate the efficacy and safety of diepalrestat (BNV-222) in diabetic patients with diabetic peripheral neuropathy. Subjects will receive twice daily an oral dose of diepalrestat, an aldose reductase inhibitor, or placebo to investigate the effect on motor nerve conduction velocity (MNCV) and symptomatic clinical responses over 12 months of treatment. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. The study will explore in a double-blind fashion, the effect of two doses of diepalrestat, 150 and 300 mg, to reduce the loss in nerve conduction velocity that is expected to be demonstrated in the group randomized to placebo treatment for up to 12 months.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This 12 month double-blind, randomized, placebo-controlled, parallel group efficacy and safety study will enroll 400 adult diabetic subjects with diabetic peripheral neuropathy (DPN) to investigate the effect of diepalrestat (BNV-222) 150 mg, 300 mg, or placebo on MNCV and patients' perception of nerve function over 12 months as measured by VAS scales and composite clinical outcome patient reported scales that evaluate numbness, tingling, cramping, paresthesiae, hyperesthesia, coldness, weakness and spontaneous pain perception of upper and lower extremities, and the effects on other measures of nerve motor and sensory conduction. Subjects will be assessed at screening and baseline, with office visits every 12 weeks, for a total of 6 visits. Subjects will be assessed by testing motor nerve conduction velocity and other assessments at each office visit. A subgroup of 24 patients will be selected for pharmacokinetic (PK) testing for up to 48 hours with additional blood draws on Day 7 and 14. This study will investigate the ability of diepalrestat to reduce the ongoing deterioration of nerve function which is a hallmark of the DPN process.

研究类型

介入性

注册 (实际的)

330

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯联邦
      • Arkhangelsk、俄罗斯联邦、163000
        • Northern State Medical University
      • Cherepovets、俄罗斯联邦、162600
        • Health Services Severstal
      • Ekaterinburg、俄罗斯联邦、620014
        • Clinic of Neurology
      • Kemerovo、俄罗斯联邦、650066
        • Kemerovo Regional Clinical Hospital
      • Moscow、俄罗斯联邦、119034
        • Endocrinology Dispensary
      • Moscow、俄罗斯联邦、119049
        • Morozovskaya Children City Hospital of Moscow
      • Moscow、俄罗斯联邦、119435
        • I M Sechenov First Moscow State Medical University
      • Moscow、俄罗斯联邦、119435
        • IM Sechenov First Moscow State Medical University
      • Moscow、俄罗斯联邦、119991
        • IM Sechenov First Moscow State Medical University
      • Moscow、俄罗斯联邦、121374
        • City Clinical Hospital No 71
      • Moscow、俄罗斯联邦、125367
        • Central Clinical Hospital No 1 of JSC Russian Railway
      • Moscow、俄罗斯联邦、127206
        • City Clinical Hospital No 50
      • Moscow、俄罗斯联邦、127486
        • The Federal Bureau of Medical and Social Expertise
      • Perm、俄罗斯联邦、614107
        • Perm State Medical Academy
      • Petrozavodsk、俄罗斯联邦、185019
        • VA Baranov Respublical Hospital
      • Rostov-on-Don、俄罗斯联邦、344022
        • Rostov State Medical University
      • Saratov、俄罗斯联邦、410053
        • City Polyclinic No 20
      • St Petersburg、俄罗斯联邦、191186
        • Imc Sogaz
      • St Petersburg、俄罗斯联邦、194295
        • Medical Center Reavita
      • St Petersburg、俄罗斯联邦、195257
        • City Hospital of the Holy Martyr Elizabeth
      • St Petersburg、俄罗斯联邦、198510
        • Nikolaev Hospital
      • Ufa、俄罗斯联邦、450000
        • Bashkir State Medical University
      • Ulyanovsk、俄罗斯联邦、432057
        • Central City Clinical Hospital
      • Volgograd、俄罗斯联邦、400131
        • State Medical University
      • Yaroslavl、俄罗斯联邦、150000
        • Regional Clinical Hospital
      • Yaroslavl、俄罗斯联邦、150003
        • NV Solovyov Clinical Emergency Hospital
    • Sestroretsk
      • St Petersburg、Sestroretsk、俄罗斯联邦、197706
        • City Hospital No 40 of the Kurortny District

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients with type 1 or type 2 diabetes mellitus that is controlled by oral or parenteral hypoglycemic agents or diet.
  • Patients with diabetes that is stable and controlled (HbA1C ≤ than 10 %) with no new symptoms associated with diabetes within previous 3 months.
  • Patients diagnosed with neuropathy who have abnormalities in 2 of 3 categories (signs, symptoms, and objective tests of nerve conduction studies or quantitative sensory threshold testing).
  • Patients on pain medication (prescribed analgesics), stable for at least 3 months before study entry or pain treatment naive.
  • Patients with at least mild painful symptoms of diabetic neuropathy for at least 1 year duration, but not longer than 10 years duration.
  • Able to withstand the fundus evaluation during ophthalmology testing

Exclusion Criteria:

  • A condition that would preclude a patient for participation in the study in opinion of investigator, e.g., unstable medical status including glycemic control and blood pressure.
  • Any neurological disorder that may confound assessment of diabetic peripheral neuropathy such as radiculopathies. multiple sclerosis, myelopathies.
  • Ongoing severe peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
  • Neuropathy findings due to any of the following: alcohol abuse, liver or renal disease, toxic exposure, endocrine, metabolic or nutritional disorders, inflammatory diseases, or monoclonal gammopathies.
  • Patients with absent peroneal nerve response.
  • Other pain that may confound assessment of neuropathic pain.
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：Group 1 150 mg
150 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of either 150 mg diepalrestat choline or placebo
药品：diepalrestat choline
aldose reductase inhibitor
其他名称：
  • BNV-222
有源比较器：Group 2 300 mg
300 mg diepalrestat choline administered as twice daily dosing morning and evening with an oral tablet of 150 mg diepalrestat choline
药品：diepalrestat choline
aldose reductase inhibitor
其他名称：
  • BNV-222
安慰剂比较：Group 3
Tablet administered twice daily morning and evening containing placebo
药品：安慰剂
安慰剂

研究衡量的是什么？

主要结果指标

结果测量
大体时间
change from baseline in peroneal motor nerve conduction velocity
大体时间：12 months
12 months

次要结果测量

结果测量
措施说明
大体时间
change from baseline in patient-reported Visual Acuity Scales
大体时间：12 months
Patients' perception of pain, numbness, tingling, weakness of the foot, ataxia, upper limb symptoms and sensory symptoms assessed by pinprick, light touch, vibration, and temperature
12 months
change from baseline in patient-reported responses to Toronto Clinical Neuropathy Score (TCNS)
大体时间：12 months
TCNS component measures of symptomatic changes in pain, numbness and other measures
12 months
change from baseline in quality of life administered by SF-36 instrument
大体时间：12 months
patient global impression of quality of life assessed by the SF-36 short form
12 months
change from baseline in median conduction velocity measurements
大体时间：12 months
conduction velocity measures including median MNCV,
12 months
change in visual acuity compared to baseline
大体时间：12 months
Change in visual acuity over 12 months compared to baseline, change in diabetic retinopathy in the dilated eye
12 months
change from baseline in MFWL conduction velocity measurement
大体时间：12 months
change from baseline in median F wave latency (MFWL)
12 months
change from baseline in VPT conduction velocity measurement
大体时间：12 months
change from baseline in Vibration Perception Threshold (VPT)
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

NeuromaxBionevia

调查人员

  • 研究主任：Julia Mockot, MD、NeuroMax Ltd.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年11月1日

初级完成 (实际的)

2017年11月1日

研究完成 (实际的)

2017年11月1日

研究注册日期

首次提交

2015年1月2日

首先提交符合 QC 标准的

2015年1月2日

首次发布 (估计)

2015年1月6日

研究记录更新

最后更新发布 (实际的)

2018年9月27日

上次提交的符合 QC 标准的更新

2018年9月26日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NM-ARI-231

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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