BOTOX® Treatment in Pediatric Lower Limb Spasticity: Open-label Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 370
- 试验地点
- 110
- 主要终点
- Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
This study will evaluate the long-term safety of BOTOX® (botulinum toxin Type A) for the treatment of pediatric lower limb spasticity.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum weight of 10 kilograms (kg)/22 pounds (lb)
- •Cerebral palsy with dynamic muscle contracture of the ankle
排除标准
- •Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
- •Uncontrolled epilepsy
- •Botulinum Toxin therapy of any serotype for any condition within the last 3 months
- •History of surgical intervention of the lower study leg within 1 year, or planned surgery of any limb during the study
研究组 & 干预措施
BOTOX®
Participants received maximum of 5 treatments of intramuscular injections of BOTOX® (botulinum toxin Type A) into a single lower limb muscles or divided between both lower limb muscles or into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart. Treatment dosing was according to investigator judgment not to exceed a maximum of 8 unit per kilogram (U/kg) of body weight (not to exceed 300 U) in treatment Cycle 1. Dose could be increased to a maximum of 10 U/kg (not to exceed 340 U) in treatment Cycles 2-5. Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 4 or 8 U/kg into the lower limb in the previous study or were de novo participants who were not enrolled in the previous study.
干预措施: Botulinum Toxin Type A (Biological)
结局指标
主要结局
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: From first dose of study drug up to 12 weeks post last dose (Up to 60 weeks)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A TEAE was an AE that occurred after receiving the first dose of investigational product or an AE present prior to first dose but increased in severity during the Treatment Period.
次要结局
未报告次要终点