Assessment of the Effectiveness of Ethosuximide in the Treatment of Peripheral Neuropathic Pain.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
研究概览
简要总结
Currently, it is established that the voltage-gated calcium channels modulate pain perception due to an influence on the neuronal transmission and excitability. In the past, attention has focused on the modulation of high voltage activated calcium channel. More recently, scientific interest has proven to the low voltage activated calcium channel, also called T-type channels. The data from the literature show significant involvement of these channels in the physiology of nociception and pathophysiology of acute and chronic pain. Moreover, in several animal pain models (acute, neuropathic, inflammatory), T-type channels inhibition alleviates painful behaviours.
Analgesics treatments available in clinic are ineffective in some patients with chronic pain (neuropathic, inflammatory) and often induce deleterious side effects. Thus, the clinical use of selective inhibitors of T-type channels could not only help the development of new therapies for the treatment of neuropathic pain (prevalence = 5-8 %), but also have a pharmaco-economic impact due to the low selling price of their inhibitor currently available: Zarontin®.
The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with peripheral neuropathic pain compared to a control group.
详细描述
This is a multicentre, parallel-group, double-blind, randomised clinical trial comparing ethosuximide and inactive control for the treatment of peripheral neuropathic pain, assessed by numerical rating scale and quality of life questionnaire.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Traumatic neuropathy or post-surgical (excluding amputations) with Neuropathic -Pain Diagnostic DN4 ≥ 4 positive and IASP criteria
- •ENS pain ≥ 4
- •ALT, AST, PAL, normal GGT, creatinine <133μmol / L, hematocrit> 38%, β-HCG
- •Patients affiliated to the French Social Security
- •Patients with free and informed consent has been obtained
- •Peripheral neuropathic pain with Neuropathic Pain Diagnostic DN4 ≥ 4 positive
排除标准
- •Pregnancy or breastfeeding
- •Diabetic neuropathy, post-herpetic neuralgia, cancer or chemotherapy-induced,
- •Patients with impaired glucose tolerance,
- •Medical and surgical history incompatible with the study,
- •History of renal disease and / or liver,
- •Addiction to alcohol and / or drugs,
- •Taking antiepileptic family carboxamides and ethosuximide
- •Use of St. John's wort,
- •Allergy succinimides (ethosuximide, methsuximide, phensuximide)
- •Psychotic disorders,
- •Patients with epilepsy,
- •Patient exclusion period, or the total allowable compensation exceeded
- •Patients undergoing a measure of legal protection (guardianship, supervision ...)
- •Central neuropathic pain
- •Other chronic pain (osteoarthritis, arthritis, fibromyalgia…) with intensity greater than neuropathic pain
研究组 & 干预措施
ethosuximide
The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a control group.
干预措施: Zarontin® (ethosuximide) and Stodal® (Drug)
control group
The purpose of this study is to assess the effectiveness of ethosuximide (Zarontin®) on the pain symptoms and quality of life in patients with neuropathic traumatic pain compared to a control group.
干预措施: Zarontin® (ethosuximide) and Stodal® (Drug)
结局指标
主要结局
Assessment of the analgesic efficacy of ethosuximide in peripheral neuropathic pain patients
时间窗: day 43
Δ = score NRS (Day 0) - score NRS (D +43)
次要结局
- Quality of life(after day 43)
- Impact of ethosuximide on neuropathic pain(after day 43)
- sleep and the overall impression of patients(after day 43)