Topiramate as a Disease Modifying Therapy for Cryptogenic Sensory Peripheral Neuropathy in Metabolic Syndrome (CSPN)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 20
- 主要终点
- Norfolk Quality of Life - Diabetic Neuropathy
研究概览
简要总结
The TopCSPN trial is a double blinded randomized placebo controlled study of oral topiramate as a potential disease modifying therapy for cryptogenic sensory peripheral neuropathy (CSPN). Patients with CSPN who also have metabolic syndrome (defined by the ATPIII criteria) who do not have an alternative cause for neuropathy will be potentially eligible. The co primary outcome measures are change in the Norfolk Quality of Life - Diabetic Neuropathy (NQOL-DN) Scale and intraepidermal nerve fiber density (IEFND) at the distal thigh. The treatment phase will last 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
An overencapsulated placebo of identical color, shape and packaging to topiramate will be used.
干预措施: Placebo (Other)
Topiramate
Oral topiramate
干预措施: topiramate (Drug)
结局指标
主要结局
Norfolk Quality of Life - Diabetic Neuropathy
时间窗: 96 weeks (expressed as a slope in change of total score/52 weeks)
Difference in NQOL between treatment groups over 96 weeks. The Norfolk QOL-DN is a validated 47-item, patient-reported outcome measure, sensitive to the different features of diabetic neuropathy (DN) including small fiber, large fiber, and autonomic function. A lower score is better. The range of the score is from -4 to 136. The slope of the change in total Norfolk QOL-DD is calculated as the change in total score/52 weeks (one year)
Intraepidermal Nerve Fiber Density (IENFD)
时间窗: 96 weeks
Difference in IENFD change between treatment groups over 96 weeks (fibers/mm) (i.e. the slope of change). A skin biopsy is obtained. The sample is stained for nerve fibers. The rate of change in IENFD in fibers/mm is calculated over the 96 week duration of the study and expressed in change in fibers/mm/year (defined as 52 weeks) over the study period (i.e. the slope of change expressed and change in IENFD in fibers/mm over a 52 week period).
次要结局
- Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Pain Interference(96 weeks (expressed as a change in change in pain interference/52weeks))
- Brief Pain Inventory - Diabetic Neuropathy (BPI-DN) Average Pain Intensity(96 weeks (expressed as a slope of change over 52 weeks))
- Utah Early Neuropathy Scale(96 weeks (expressed as a slope of change in total UENS over 52 weeks).)
- Sural Sensory Amplitude (SSA)(96 weeks (slope of change in mV/52weeks))
- Peroneal Motor Conduction Velocity (PMCV)(96 weeks (expressed as a slope of change in meter/sec over 52 weeks))
- Body Mass Index (BMI)(96 weeks (slope of change in kg/m2/52 weeks))
- Hemoglobin A1C(The annual slope of the change in A1C over 96 weeks expressed in change in percent/52 weeks)
- Serum Triglycerides (TRG)(96 weeks (slope of change mg/dl over 52 weeks))
- LDL Cholesterol(96 weeks (expressed as a slope of change in mg/dl/52 weeks))
- HDL Cholesterol(96 weeks (expressed as slope of change in mg/dL/52 weeks))