NCT04431778招募中2 期
Evaluation of the Efficacy and Tolerance of Low Doses of Ethosuximide in the Treatment of Peripheral Neuropathic Pain
University Hospital, Clermont-Ferrand11 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 11
- 主要终点
- Neuropathic pain intensity
研究概览
简要总结
Evaluation of the efficacy and tolerance of low doses of ethosuximide in the treatment of peripheral neuropathic pain
详细描述
Multicenter, randomized, double-blind, placebo-controlled therapeutic trial evaluating the efficacy and safety of low doses of ethosuximide in neuropathic pain patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind Placebo and ethosuximide will be indistinguishable.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (under effective contraception: pill, implant, IUD, sterilization) aged 18 years or older, suffering from peripheral neuropathic pain (DN4 ≥ 4) for more than 3 months, of intensity ≥ 4 on a numerical scale from 0 to 10, and whose analgesic treatment has been stable for more than a month,
- •Patients affiliated to the French Social Security system,
- •Patients whose free and informed consent has been obtained.
排除标准
- •Pregnancy (βHCG+ blood) or breastfeeding,
- •Neuropathic pain due to spinal cord or brain injury, phantom limb pain or algohallucinosis,
- •Fibromyalgia or algodystrophy,
- •Chronic pain syndrome that the patient cannot distinguish and/or is more intense than peripheral neuropathic pain,
- •Significant abnormalities in liver (transaminases > 3N, cholestasis) and renal (MDRD < 60 mL/min) tests,
- •Ongoing comorbidities: cancer, neurodegenerative pathology
- •Severe depressive disorder in progress (as determined by the clinician), history of suicide attempts or hospitalization for depression,
- •Diabetic patients (contraindicated due to the high sugar concentration of ethosuximide, 3g / 5 ml),
- •Patients who have previously received ethosuximide (epilepsy or clinical trial),
- •Surgery planned throughout the entire trial,
- •Medical and surgical history incompatible with the study,
- •Dependence on alcohol and/or drugs (for compliance purposes),
- •Known allergy to succinimides (ethosuximide, methsuximide, phensuximide),
- •Psychotic disorders,
- •Epileptic patients,
- •Patients benefiting from a legal protection measure (curatorship, guardianship, deprived of liberty or subject to judicial safeguard).
研究组 & 干预措施
Ethosuximide
Experimental
Patients with chronic peripheral neuropathic pain
干预措施: Ethosuximide (Drug)
Placebo
Placebo Comparator
Patients with chronic peripheral neuropathic pain
干预措施: Placebo (Drug)
结局指标
主要结局
Neuropathic pain intensity
时间窗: Day 84
Variation in pain intensity (NRS, Numerical Rating Scale 0-10) averaged over the 7 days prior to the start of treatment (D0) and over the last 7 days of treatment (12 weeks).
次要结局
- Patient's Global Impression of Change (PGIC scale)(Day 0, Day 28, Day 56, Day 84)
- Health related quality of life(Day 0, Day 28, Day 56, Day 84)
- Quantitative sensory testing (QST)(Day 0, Day 28, Day 56, Day 84)
- adverse event(Throughout the study)
研究者
研究点 (11)
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