Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
研究概览
简要总结
Objective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.
详细描述
Objective
To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia.
Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: dystonia rating scales (TWISTRS)
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
cervical dystonia
cervical dsytonia patinets
干预措施: Amlodipine plus Botulinum toxin (Drug)
结局指标
主要结局
Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
时间窗: 1-2 month maximal rating
Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.
次要结局
- Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo(3 months)
研究者
Barbara Karp, M.D.
MD
National Institutes of Health Clinical Center (CC)