NCT01259557已完成4 期
Multi-center, Phase Ⅳ, Single Arm, Open-label Clinical Trial to Evaluate the Efficacy and Safety of Meditoxin® in Subjects With Essential Blepharospasm
Medy-Tox3 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- the change rate of Jankovic Rating Scale score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Meditoxin® in the treatment of Essential blepharospasm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged above 18
- •Subjects who was diagnosed with Essential Blepharospasm
- •Subjects who voluntarily Signed written informed consent
- •Subjects who can adhere to protocol and study requirements
排除标准
- •Subjects with known history of allergy considered due to Botulinum toxin type A
- •Subjects who have received botulinum toxin A type within 3 months
- •Any disease that might affect neuromuscular function (e.g.. Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis ect.)
- •Subjects who are participating in other clinical trials
- •Pregnant or lactating female Subjects
- •Subjects who are not eligible for the study at the discretion of the Investigator.
研究组 & 干预措施
Botulinum toxin type A(Meditoxin®)
Experimental
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
the change rate of Jankovic Rating Scale score
时间窗: 4weeks
To evaluate the change of JRS(Jankovic Rating Scale) score at 4 weeks post treatment based on baseline( 0 week).
次要结局
- the change rate of Jankovic Rating Scale scale(0 week, 16weeks(or retreatment point))
- the change rate of Blepharospasm Disability Index(0week, 4weeks, 8weeks, 16weeks(or retreatment point))
- Global assessment about the improvement(4weeks)
- the duration of efficacy(retreatment point or 16 weeks)
研究者
研究点 (3)
Loading locations...
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