NCT02188277已完成2 期
Multi-center Open Comparative Randomized Trial of Clinical and Neurophysiological Efficacy and Safety of Xeomin (Botulinum Toxin Type A) vs. Botox (Complex of Botulinum Toxin Type A and Hemagglutinin) in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
研究概览
简要总结
- To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy
- To assess the safety of Xeomin® use as compared to Botox® in this patient population
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
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 2 through 12 years of age, of both sexes, suffering from spastic paraplegia or hemiparesis in pediatric cerebral palsy.
- •Equine and equinovarus foot posture.
- •Gastrocnemius spasticity of 2 points and greater, by modified Ashworth scale.
- •Patient can walk unassisted or with a support.
- •Mental development of patients is normal or mildly retarded.
- •Previous course of spasticity treatment with BTA products was completed earlier than at 6 months before this trial or never administered before.
- •Patient's parents have signed an informed consent, are able and wishing to adhere to procedures described in the trial protocol and to the schedule of visits throughout the entire period of treatment.
排除标准
- •Fixed ankle joint contracture.
- •Previous denervation of spastic muscles by surgery, phenol or alcohol;
- •Athetosis and dystonia in the area of injected muscles.
- •Inflammation at the planned injection site.
- •Elevated body temperature and acute (infectious and non-infectious) diseases at the time of injection.
- •Neuromuscular transmission disorders (myasthenia gravis, Lambert-Eaton syndrome, etc.).
- •Decompensated physical diseases potentially affecting the trial findings.
- •Acute fever, infection or surgery within 1 month before the trial.
- •Use of aminoglycosides or spectinomycin within 1 month before starting the trial.
- •Hypersensitivity to any of product ingredients.
- •Positive history for allergies (especially with regard to protein-containing products).
- •Patient's parents are unable or unwilling to adhere to the trial protocol requirements including signing the informed consent and conforming to the schedule of visits.
- •Participation in other clinical trials in the last 4 weeks before inclusion.
研究组 & 干预措施
Xeomin®
Experimental
4-8 Units per kg body weight. Single injection cycle.
干预措施: Xeomin (Drug)
Botox®
Active Comparator
4-6(8) Units per kg body weight. Single injection cycle.
干预措施: Botox® (Drug)
结局指标
主要结局
Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale (AS)
时间窗: From baseline to day 30
The AS is a well known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
次要结局
- Changes from baseline in the ratio of M-response recorded from the lateral and medial gastrocnemius heads and from tibialis anterior(From baseline up to day 90)
- Changes from baseline in angles and angle ratio of ankle joints at passive and voluntary extension(From baseline up to day 90)
- Changes from baseline in the degree of spasticity in gastrocnemius according to modified Ashworth scale(Baseline up to day 90)
- Percentage of decrease in M-response magnitude and area recorded from the lateral and medial gastrocnemius heads, from baseline values(From baseline up to day 90)
- Changes from baseline in motor activity according to Gross Motor Function Classification Systems (GMFCS) criteria(From baseline up to day 90)
- Changes from baseline in patient percentage in groups by the degree of gastrocnemius spasticity according to modified Ashworth scale(From baseline up to day 90)
研究者
研究点 (3)
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