EUCTR2021-006048-29-IT进行中（未招募）1 期
BotulInum toxin type A for peripheral Neuropathic pain in subjEcts with Carpal Tunnel syndrome: a multicenter, randomized, double-blind, placebo-controlled study - BotulInum toxin type A for peripheral Neuropathic pain
AOU MATERDOMINI0 个研究点目标入组 164 人开始时间: 2021年12月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A participant will be eligible to enroll in the study only if all the following criteria are met: a) The participant is a male or female subject aged =18 and =60 years old; b) The participant meets the criteria for probable or definite NP according to the International Association for the Study of Pain [Treede 2008]; c) The participant has been having daily pain, attributable to CTS, for at least 6 months; d) The pain level is rated as moderate–severe (4–8 points) according to the 11-point NRS; e) The participant is able and willing to provide written informed consent; f) We allow the concomitant use of analgesic treatments if they have been used at a stable doses for 4 weeks before the enrolment and for the whole study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 164
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient will be ineligible for enrolment in this study if any of the following criteria are met: 1) The pain level is rated as =9 on the 11-point NRS; 2) The participant has CTS with atrophy of median-innervated muscles; 3) The participant presents contraindications or hypersensitivity to BoNT-A; 4) The participant suffers from disorders of the neuromuscular junction, coagulation disorders, or major psychiatric disorders; 5) The participant is using drugs acting on neuromuscular junctions, topical drugs (e.g., capsaicin or lidocaine), or anesthetic blocks; 6) The participant has diabetes, rheumatoid arthritis, connective tissue diseases, vasculitis, untreated hypothyroidism, acromegaly. 7) The participant has previously used BoNT-A; 8) The participant is pregnant or breastfeeding; 9) The participant is enrolled in another interventional trial for the treatment of the same disease.
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