NCT01384214已完成4 期
Pilot Study of the Effect of Botulinum Toxin Type A Treatment on Swallowing in Patients With Cervical Dystonia
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
研究概览
简要总结
The purpose of this study is to evaluate swallowing efficiency in patients with cervical dystonia following treatment with botulinum toxin Type A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with cervical dystonia
- •Successfully completed Allergan study MedAff BTX-0616 with 16 weeks since last botulinum toxin Type A injection
- •In need of additional botulinum toxin Type A injections
排除标准
- •Surgery or spinal cord stimulation for cervical dystonia
- •Previous injections of phenol or alcohol for cervical dystonia
结局指标
主要结局
Change from Baseline in Oropharyngeal Swallow Efficiency (OPSE)
时间窗: Baseline, Week 2
次要结局
- Toronto Western Spasmodic Torticollis Scale (TWSTRS) Total Score(Week 4)
- Physician Assessment of Cervical Dystonia Severity(Week 4)
- Global Assessment of Benefit by Physician(Week 4)
- Global Assessment of Benefit by Patient(Week 4)
- Patient Visual Analog Assessment of Pain(Week 4)
研究者
研究点 (1)
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