NCT01664013Unknown4 期
The Impact of Botulinum Toxin Treatment in Quality of Life of Cervical Dystonia Patients
Roongroj Bhidayasiri1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.
研究概览
简要总结
The purpose of this study is to investigate the impact of botulinum toxin treatment in quality of life(QoL) in cervical dystonia patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years to 75 years
- •Subjects requiring treatment for a clinical diagnosis of cervical dystonia
- •Willing to provide written informed consent before any study-related procedures.
排除标准
- •Patients with pure anterocollis
- •Patients with an anaphlyactic response history to botulinum toxin type A.
- •Patients who have been treated with botulinum toxin type A within 3 month.
- •Females who are pregnant, planning pregnancy, unable to use contraception or lactating.
- •Any medical condition that may put the subject at increased risk with exposure to botulinum toxin at the discrimination of investigators.
研究组 & 干预措施
Neuronox
Experimental
Neuronox® is a botulinum toxin type A (BoNT/A) product developed by Medytox Inc. (Medytox) of Korea. Neuronox® was first approved by the Korean Food and Drug Administration in 2006, and by Thai Food and Drug Administration in 2008.
干预措施: Nuronox (Drug)
结局指标
主要结局
To investigate the change of quality of life of cervical dystonia patients after botulinum toxin treatment measured by CDQ-24.
时间窗: 6 weeks
To investigate the change of quality of life of cervical dystonia patients from baseline at 6 weeks after botulinum toxin treatment measured by CDQ-24.
次要结局
- To investigate the change of QoL of cervical dystonia patientsafter botulinum toxin treatment measured by SF-36 (Thai version)(6 weeks)
- To Investigate the change of symptom after botulinum toxin treatment measured by TWSTRS score(6 weeks)
研究者
Roongroj Bhidayasiri
Associate Professor
Chulalongkorn University
研究点 (1)
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