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临床试验/NCT00173745
NCT00173745Unknown不适用

Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年6月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
the effectiveness of botulinum toxin in treatment of drooling

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

详细描述

Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
6 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of cerebral palsy
  • severe drooling
  • aged 6-21 yrs
  • subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form

排除标准

  • age below 6 yrs or above 21 yrs
  • known allergy or sensitivity to the study medication or its component
  • diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function
  • subjects who have prior surgery of the submandibular gland
  • subjects who are receiving medication that affect drooling such as anticholinergic drug
  • inability to give informed consent

结局指标

主要结局

the effectiveness of botulinum toxin in treatment of drooling

次要结局

  • the most appropriated dosage of treatment
  • duration of effect
  • side effects

研究者

申办方类型
Other

研究点 (1)

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