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临床试验/NCT03331913
NCT03331913Unknown3 期

The Efficacy and Safety of Botulinum Toxin for the Treatment of Trigeminal Neuralgia: Comparison of Two Different Treatment Methods

The First Affiliated Hospital of Zhengzhou University5 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年11月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
150
试验地点
5
主要终点
Pain relief

研究概览

简要总结

Trigeminal neuralgia (TN) is one of the most painful and common types of neuropathic pain encountered by clinicians. It is typically treated pharmacologically with anticonvulsants,but these can be ineffective, or can lose their effectiveness over time.Botulinum toxin type A (BoNT-A) is an exotoxin released by the Gram-positive, anaerobic bacillus Clostridium botulinum that causes flaccid paralysis by blocking neurotransmitter release by axonal terminals. As a contaminant, it is the cause of potentially lethal botulism poisoning; however, as a drug, it has been widely used in the treatment of dystonia, as well as for non-surgical cosmetic treatment. More recently, studies investigating the ability of BoNT-A to treat pain have been increasing. In 2012, the investigators reported the results of a randomized, double-blind, and placebo-controlled trial in which subcutaneous injection of BoNT-A at the site of pain provided long-term effective relief in TN. The investigators noted that adverse effects were mild, as well. Other studies on TN have estimated the effectiveness of BoNT-A treatment in TN to be 47-73%. However, BoNT-A treatment is still ineffective in more than 30% of patients.In this study, the investigators investigate whether different treatment methods have different efficacy and safety.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years
  • Clinical diagnosis of classical trigeminal neuralgia according to the ICHD III (beta)
  • The pain involved the gingiva
  • Signed informed consent prior to entering study

排除标准

  • comorbid diseases that may be exacerbated by botulinum toxin type A (e.g., myasthenia gravis, motor neuron disease, or Lambert-Eaton syndrome).
  • receiving drugs with neuromuscular junction toxicity 1 week before botulinum toxin type A treatment (e.g. quinine, aminoglycosides or penicillamine)
  • had an infection of the skin or mucosa at any of the injection sites.
  • psychiatric illness.
  • malignancy.
  • pregnancy or lactation.
  • currently participating or previously participated in any investigational drug or device study within 6 months.

研究组 & 干预措施

intradermal / submucosal injection group

Active Comparator

intradermal / submucosal injection at pain area

干预措施: Botulinum Toxin type A (intradermal / submucosal injection at pain area) (Drug)

intra-masseter injection group

Experimental

intra-masseter injection on the ipsilateral of pain involved

干预措施: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) (Drug)

结局指标

主要结局

Pain relief

时间窗: 4 weeks

Pain relief was defined as ≥50% reduction in Visual Analogue Scale score which is an 11 point scale from 0 - 10 with 0 being no headache

次要结局

  • Visual Analogue Scale score(12 weeks)
  • The overall response to treatment on the Patient Global Impression of Change(8 weeks)

研究者

发起方
The First Affiliated Hospital of Zhengzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chuanjie Wu

MD, PhD

The First Affiliated Hospital of Zhengzhou University

研究点 (5)

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