NCT01392300已完成3 期
Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Upper Limb
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 47
- 主要终点
- Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
研究概览
简要总结
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the upper limb are effective in treating spasticity in patients after stroke.
详细描述
The study consists of a randomized, double-blind, placebo-controlled, parallel-group, single-dose main period followed by an open-label, non-controlled, repeated-dose extension period (Open-Label Extension Period - OLEX).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper limb spasticity
- •Time since stroke greater than 3 months
- •Need for 400 U Botulinum toxin type A
排除标准
- •Body weight below 50kg
- •Fixed contractures of the upper limb
- •Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin Type A
- •Infection at the injection site
研究组 & 干预措施
DB IncobotulinumtoxinA (Xeomin) (400 U)
Experimental
IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment
干预措施: IncobotulinumtoxinA (400 Units) (Drug)
DB Placebo Comparator
Placebo Comparator
Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind (DB), randomized treatment assignment
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Change From Baseline in Ashworth Scale (AS) Score of Primary Target Clinical Pattern
时间窗: Week 4
Primary target clinical pattern was defined by investigator for each subject at baseline visit and was either flexed wrist or clenched fist or flexed elbow. The Ashworth Scale is well known and commonly used in clinical trials with spasticity. It was used to categorize severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
Investigator's Global Impression of Change
时间窗: Week 4
This is the co-primary outcome measure. The Global Impression of Change Scale \[GICS\] is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.
次要结局
- Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Elbow(Week 4)
- Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Elbow(Week 8)
- Response Rates on the Ashworth Scale at Week 4 Calculated for the Primary Target Clinical Pattern(Week 4)
- Response Rates on the Ashworth Scale at Week 8 Calculated for the Primary Target Clinical Pattern(Week 8)
- Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Flexed Wrist(Week 8)
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Primary Target Clinical Pattern(Week 12)
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Wrist(Week 12)
- Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.(Week 4)
- Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Flexed Wrist(Week 4)
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Flexed Elbow(Week 12)
- Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Clenched Fist(Week 4)
- Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Clenched Fist(Week 8)
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Clenched Fist(Week 12)
- Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Thumb-in-palm(Week 4)
- Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Thumb-in-palm(Week 8)
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Thumb-in-palm(Week 12)
- Response Rates on the Ashworth Scale at Week 4 Calculated for the Muscle Group Pronated Forearm(Week 4)
- Response Rates on the Ashworth Scale at Week 8 Calculated for the Muscle Group Pronated Forearm(Week 8)
- Response Rates on the Ashworth Scale at Week 12 Calculated for the Muscle Group Pronated Forearm(Week 12)
- Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.(Week 4)
- Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.(Week 8)
- Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.(Week 8)
- Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Wrist.(Week 12)
- Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.(Week 4)
- Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.(Week 8)
- Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Flexed Elbow.(Week 12)
- Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.(Week 4)
- Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.(Week 8)
- Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Clenched Fist.(Week 12)
- Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Thumb-in-palm.(Week 12)
- Changes From Baseline to Week 4 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.(Week 4)
- Changes From Baseline to Week 8 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.(Week 8)
- Changes From Baseline to Week 12 in Ashworth Scale Score for Treated Muscle Group Pronated Forearm.(Week 12)
- Changes From Baseline to Week 4 in Disability Assessment Scale - Principal Therapeutic Target Domain(Week 4)
- Changes From Baseline to Week 8 in Disability Assessment Scale - Principal Therapeutic Target Domain(Week 8)
- Changes From Baseline to Week 12 in Disability Assessment Scale - Principal Therapeutic Target Domain(Week 12)
- Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Hygiene(Week 4)
- Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Hygiene(Week 8)
- Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Hygiene(Week 12)
- Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Dressing(Week 4)
- Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Dressing(Week 8)
- Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Dressing(Week 12)
- Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Limb Position(Week 4)
- Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Limb Position(Week 8)
- Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Limb Position(Week 12)
- Changes From Baseline to Week 4 in Disability Assessment Scale - Domain Pain(Week 4)
- Changes From Baseline to Week 8 in Disability Assessment Scale - Domain Pain(Week 8)
- Changes From Baseline to Week 12 in Disability Assessment Scale - Domain Pain(Week 12)
研究者
研究点 (47)
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