NCT01787344已完成3 期
Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy of "Botulax®" Versus "Botox®" in Children With Cerebral Palsy
Hugel6 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 6
- 主要终点
- Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
研究概览
简要总结
To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral palsy in children.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children patients ages from 2years old to 10years old.
- •Patients who diagnosed with cerebral palsy.
- •Patients who diagnosed as Gross Motor Function Classification System level I, II, or III
- •Patients who diagnosed as dynamic equinus foot deformity
- •Patients who agree with participation and signed to written agreement by substitute. (Get a signature from children patients if possible)deformity and I, II or III level of Gross Motor Function Classification System
排除标准
- •Patients who had previous injection of other botulinum toxin products in 3 months
- •Patients with hypersensitivity history to botulinum toxin products previously
- •Patients with neuromuscular junction disorder (myasthenia gravis, Lambert- Eaton syndrome, or amyotrophic lateral sclerosis, etc.)
- •Those who have severe cardiovascular, kidney, liver, or respiratory diseases
- •Those who are taking anticoagulant drugs or have bleeding disorder.
- •Pratients with treatment of following drugs: Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen, blockers of parasympathetic nervous system, and levodopa.
- •Patients who had history of surgery, plan to have surgery on legs, foot, or ankle.
- •Patients who have evidence of fixed contractures regarding to Investigator
- •Patients who have difference between two legs over 5cm
- •Patients with severe athetoid movement
- •Patients who had other treatments related to dynamic equinus foot deformity, such as alcohol injection or muscle relaxants
- •Those who were not enrolled in other studies within 30 days, or were not paseed over 5 times of half life for clinical trial drugs.
- •Patients who have possibility to take prevented drugs
- •Subjects who are not eligible for this study based on investigator's judgement
研究组 & 干预措施
Botulinum toxin type A (Botulax®)
Experimental
Botulinum toxin type A (Botulax®)
干预措施: Botulinum toxin type A(Botulax®) (Drug)
Botulinum toxin type A(Botox®)
Active Comparator
Botulinum toxin type A(Botox®)
干预措施: Botulinum Toxin Type A(Botox®) (Drug)
结局指标
主要结局
Rate of patients with an improvement more than two grade in Physician's Rating Scale score.
时间窗: at 12 weeks post-injection
次要结局
- Rate of patients with an improvement more than two grade in Physician's Rating Scale score, comparing to baseline.(at 6 and 24weeks post-injection)
- Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.(at 6, 12 and 24 weeks post-injection)
- Rate of change in Passive range of motion, compare to baseline.(at 6, 12 and 24 weeks post-injection)
- Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.(at 6, 12 and 24 weeks post-injection)
研究者
研究点 (6)
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