Randomized Double Blind Placebo Controlled Multicenter Study of the Efficacy and Safety of Repeated Administrations of Botulinum Toxin Type A (Botox) in the Treatment of Peripheral Neuropathic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Average pain intensity on numerical scales in a self diary by the patient
研究概览
简要总结
Pain due to peripheral nerve lesion remains extremely difficult to treat and current treatments have onl moderate efficacy and/or side effects. The investigators have previously demonstrated the long term efficacy of Botulinum toxin type A (BTX-A) in a small group of patients with post-traumatic/postherpetic neuralgia and allodynia. The present study aims to a/ confirm the efficacy of repeated applications of BTX-A in a larger group of patients with peripheral neuropathic pain with or without allodynia(primary outcome) ; b/ evaluate its mechanisms of action ; c/analyse the predictors of response ;d/analyse whether the second injection is associated with a therapeutic gain. This will be a randomized placebo controlled study. A total of 30 patients will be randomized to receive either BTX-A (subcutaneous injection in the painful area) or placebo. Each injection will be repeated within at least 3 months depending on the duration of efficacy. Skin punch biopsies will be performed before and 1 month after BTX-A administration. The investigators postulate that this study will confirm the clinical efficacy and good safety of repeated administrations of BTX-A in the treatment of peripheral neuropathic pain.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 to 85 years Spontaneous pain with a minimal intensity of 4/10 on numerical scle Pain present for at least 6 months Pain related to painful mononeuropathy or sensory polyneuropathy Able to understand the protocol and comply to the requirements of the study Written informed consent Painful area limited to a maximum of 240 cm2
排除标准
- •Facial pain Litigation (pending) Unstable condition responsible for neuropathic pain (ie, unstable immunological disease...) HIV or chemotherapy induced neuropathy Contraindications to BTX-A (neuromuscular disease, hypersensitivity, infection, coagulation disorder, pregnancy) Other pain more severe than neuropathic pain No compliance with the self diary Drug abuse or alcoholism Severe major depression Cognitive impairment Other research protocol within the last 30 days
研究组 & 干预措施
botulinum toxin type A
botulinum toxin type A will be injected subcutaneously in the painful area (maximum 300 units)
干预措施: botulinum toxin type A (Drug)
sodium chloride 9 %
sodium chloride 9 % will be used as a neutral placebo
干预措施: botulinum toxin type A (Drug)
结局指标
主要结局
Average pain intensity on numerical scales in a self diary by the patient
时间窗: every day from baseline for up to 6 months
Numerical scales (0-10)
次要结局
- Efficacy of treatment on neuropathic symptoms(at each visit)
- Quality of life VAS(at each visit)
- Intensity of allodynia to brush(at each visit)
- assessment of effects of BTX-A on substance P and CGRP(at baseline and 1 month after BTX-A or placebo)
- Side effects(throughout the study and each each visit)
- Detection and pain thresholds to mechanical and thermal stimuli and responses to suprathreshold stimuli(at each visit)
- Predictors of the response(Up to 6 months)
研究者
Nadine ATTAL
Clinical principal investigator
Hospital Ambroise Paré Paris