Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Safety and Efficacy of MEDITOXIN® in Children With Cerebral Palsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- Mean change from baseline in MAS score from baseline to week 4
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 children with cerebral palsy.
详细描述
The allocated subject is injected Meditoxin® 4U/kg body weight(for patients with hemiplegia) or 6U/kg body weight(for patients with diplegia)in the affected gastrocnemius muscle for the treatment of patients who suffer Equinus Foot Deformity with pediatric cerebral palsy due to spasticity.
The efficacy and safety are evaluated for 12weeks through 3 follow up visits.
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
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients aged between 2 and 18 years with diagnosis of spastic cerebral palsy
- •Patients with toe-walking due to peroneal muscle spasticity (patients with equinus foot deformity due to spasticity)
- •Patients who voluntarily consent to participate in this study and whose legally acceptable representative has signed the informed consent form (if the patient is able to write, his/her signature should be also obtained).
排除标准
- •Patients who had previously received botulinum toxin within 3 months prior to the study entry
- •Patients with known hypersensitivity to botulinum toxin
- •Patients who requires legs, feet or ankle surgery at present
- •Patients with severe athetoid movement
- •Patients who is participating in other investigational study at present
- •Patients, by the investigator's discretion, who are not suitable for this study.
研究组 & 干预措施
Treatment Group 1
Meditoxin
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Mean change from baseline in MAS score from baseline to week 4
时间窗: 4 weeks
The investigator assessed MAS score using a 5-point scale (0, 1, 1+, 2, 3, and 4; 0=No increase in muscle tone to 4=Affected part\[s\] rigid in flexion or extension) The "+1" (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder \[less than half\] of ROM \[range of motion\]) of MAS score is regarded as score 2
次要结局
- Mean change from baseline in MAS score from baseline to week 12(12 weeks)
- Mean change from baseline in VAS(Visual Analogue Scale)assessed by caregiver/patient from baseline to week4(4, 12 weeks)
- Mean change from baseline in PROM(Passive Range of Motion of ankle) at ankle dorsiflexion from baseline to week 4, 12(4, 12 Weeks)
- Improvement in Global Assessment assessed by caregiver/patient(4, 12 weeks)