NCT01860196已完成4 期
A Placebo Controlled, Cross-over, Double Blind, Randomized, Clinical Trial to Compare the Efficacy and Safety of Meditoxin® Injection for Cervical Dystonia in Adults With Cerebral Palsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
研究概览
简要总结
This study aimed to compare the efficacy and safety of Meditoxin® injection for cervical dystonia in adults with cerebral palsy. It is a placebo controlled, Cross-over, Double blind, Randomized, Clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult cerebral palsy patients over 20 years old
- •Clinically diagnosed for cervical dystonia more than a year ago
- •No improvement with antispasmodics for the last month
- •Actively participated and gave informed consent
排除标准
- •Allergic to the botulinum toxin
- •Limited range of motion in cervical spine
- •Patients with fever, infection, cancer, uncontrollable seizure
- •Generalized neuromuscular junction disease patients
- •Pregnant or breast feeding women, or anticipating pregnancy until 12 weeks after the study stopped
- •Patients enrolled in other studies
- •History of dose change in 4 weeks: antispasmodics, benzodiazepine, anticholinergics
- •Botulinum toxin injection history in 6 months
- •Previous history of intrathecal baclofen, selective peripheral denervation, deep brain stimulation
- •Otherwise clinically non-eligible patients
研究组 & 干预措施
Treatment-Placebo Group
Active Comparator
Treatment on 0 day Placebo at 5th week
干预措施: Meditoxin (Drug)
Placebo-Treatment Group
Active Comparator
Placebo on 0 day Treatment at 5th week
干预措施: Normal saline (Drug)
结局指标
主要结局
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
时间窗: 0, 16, 32 weeks
Change of Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline TWSTRS at 0 week.
次要结局
- Pain in numerical rating scale (NRS)(Every 4 weeks, up to 32 weeks)
- Japanese Orthopaedic Association (JOA) score(Every 4 weeks, up to 32 weeks)
- Goal attainment scale(4, 12, 20, 28 weeks)
研究者
Keewon Kim
Professor
Seoul National University Hospital
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