NCT01603459已完成3 期
Prospective, Open-label, Non-randomized, Single-arm, Multi-center Dose Titration Study to Investigate the Safety and Efficacy of NT 201 in Subjects Deemed to Require Total Body Doses of 800 U of NT 201 During the Course of the Study for the Treatment of Upper and Lower Limb Spasticity of the Same Body Side Due to Cerebral Causes
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
- 155
- 试验地点
- 33
- 主要终点
- Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication
研究概览
简要总结
The purpose of this study is to determine whether injections with increasing doses (up to 800 units) of Botulinum toxin type A into muscles of the leg and/or arm are safe and effective in treating patients with spasticity on one body side due to cerebral causes.
详细描述
A dose-titration approach will be used over three injection cycles, with a flexible observation period after injections of 12-16 weeks and a total duration of up to 48 weeks. Cycle 1 and 2: upper and/or lower limb to be treated; Cycle 3: upper and lower limb to be treated.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper and lower limb spasticity of the same body side due to cerebral causes
- •Time since event leading to spasticity in the target body side greater than 12 weeks
- •Need for 800 units Botulinum toxin type A
排除标准
- •Body weight below 50kg
- •Fixed contractures of the target joint
- •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
IncobotulinumtoxinA (Xeomin) (up to 800 Units)
Experimental
IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
干预措施: IncobotulinumtoxinA (Drug)
结局指标
主要结局
Occurrence of Treatment-Emergent Adverse Events (AEs), AEs of Special Interest (AESIs), and Serious AEs (SAEs) by Injection Cycle, Overall and Related to the Administration of Study Medication
时间窗: From baseline to week 36-48
Treatment-emergent Adverse Events (TEASs) are events observed from the time point of first injection until 16 weeks after last injection. Values reported here refer to the number of subjects affected.
Investigator's Global Assessment of Tolerability in Subjects
时间窗: Up to Week 48
A 4-point Likert scale was used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor.
次要结局
- Ashworth Scale (AS) Scores of the Target Joint Selected at Study Baseline Visit(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Injection Cycle Baseline Visits to Respective Control Visits(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Control Visits of Injection Cycles(From Study Baseline to Week 4, 16-20 and 28-36)
- Change of Ashworth Scale (AS) Score of the Target Joint Selected at Study Baseline Visit From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit(From Study Baseline to Week 12-16, 24-32 and 36-48)
- Ashworth Scale (AS) Scores of Every Joint Affected by Clinical Patterns of Spasticity(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Injection Cycle Baseline Visits to Respective Control Visits(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Control Visits of Injection Cycles(From Study Baseline to Week 4, 16-20 and 28-36)
- Change of Ashworth Scale (AS) Score of Every Joint Affected by Clinical Patterns of Spasticity From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit(From Study Baseline to Week 12-16, 24-32 and 36-48)
- Resistance to Passive Movement Scale (REPAS) Scores of Treated Side(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Injection Cycle Baseline Visits to Respective Control Visits(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Control Visits of Injection Cycles(From Study Baseline to Week 4, 16-20 and 28-36)
- Change of Resistance to Passive Movement Scale (REPAS) Score of Treated Side From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit(From Study Baseline to Week 12-16, 24-32 and 36-48)
- Functional Ambulation Classification (FAC) Scale Scores(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Functional Ambulation Classification (FAC) Score From Injection Cycle Baseline Visits to Respective Control Visits(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Control Visits of Injection Cycles(From Study Baseline to Week 4, 16-20 and 28-36)
- Change of Functional Ambulation Classification (FAC) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit(From Study Baseline to Week 12-16, 24-32 and 36-48)
- Goal Attainment Scale (GAS) Scores for Upper and Lower Limb, Respectively(From Cycle Baseline Visit to Week 12-16, 24-32 and 36-48)
- Disability Assessment Scale (DAS) Scores in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb(From Cycle Baseline to Week 4 of Each Cycle)
- Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Injection Cycle Baseline Visits to Respective Control Visits(Week 4 of Each Cycle)
- Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Control Visits of Injection Cycles(From Study Baseline to Week 4, 16-20 and 28-36)
- Change of Disability Assessment Scale (DAS) Score in a Selected Principal Therapeutic Target Domain Affecting the Upper Limb From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit.(From Study Baseline to Week 12-16, 24-32 and 36-48)
- Global Assessment of Efficacy Scores(Week 12-16, 24-32 and 36-48)
- EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores(From Cycle Baseline to Week 4 of Each Cycle)
- Visual Analogue Scale (VAS) of EuroQoL 5-Dimensions Questionnaire (EQ-5D) Scores(From Cycle Baseline to Week 4 of Each Cycle)
- Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits(From Cycle Baseline to Week 4 of Each Cycle)
- Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Injection Cycle Baseline Visits to Respective Control Visits(From Cycle Baseline to Week 4 of Each Cycle)
- Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles(From Study Baseline to Week 4, 16-20 and 28-36)
- Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Control Visits of Injection Cycles(From Study Baseline to Week 4, 16-20 and 28-36)
- Change of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit(From Study Baseline to Week 12-16, 24-32 and 36-48)
- Change in Visual Analogue Scale of EuroQoL 5-dimensions Questionnaire (EQ-5D) Score From Study Baseline Visit to Injection Cycle Baseline Visits and End of Cycle 3 Visit(From Study Baseline to Week 12-16, 24-32 and 36-48)
研究者
研究点 (33)
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