Oral Zinc Supplementation to Enhance Effects of Botulinum Neurotoxin Injection: an n of 1 Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Patient Global Impression of Change
研究概览
简要总结
Botulinum neurotoxin (BoNT) is injected into muscles for treatment of dystonia. BoNTs are zinc proteases, and their enzymatic effect is reduced in the setting of low zinc. The study hypothesis is that a large enough fraction of unselected dystonia patients receiving BoNT injection have suboptimal zinc concentration in their tissues, and will experience improved response to BoNT if the injection is preceded by oral zinc supplementation (OZS). OZS consists of 50 mg of zinc acetate oral tablet each day for 7 days before injection. This is a double blind placebo controlled cross-over study, randomized order placebo and OZS, in patients at a neurology clinic on stable dose of BoNT.
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)
盲法说明
Pharmacy prepares vials labeled A and B, and reveals code to PI after data lock
入排标准
- 年龄范围
- 18 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the PI
- •Age 18-80
- •Male or female
- •With an approved indication for BoNT such as dystonia or hemifacial spasm
- •Have received either two or three BoNT injection cycles within the prior 8 months
- •Prior two injection cycles length differed by no more than 2 weeks
- •Prior two injection cycles used same brand of BoNT and similar dose within 15%
排除标准
- •Concommitant use of penicillamine or cisplatin
结局指标
主要结局
Patient Global Impression of Change
时间窗: End of study, week 48
Patient selects one of three options: My response to BoNT injection with bottle A tablets was overall better than with bottle B tablets; My response to BoNT injection with bottle B tablets was overall better than bottle A tablets; or Neither BoNT injection with bottle A or with bottle B tablets was overall better than the other
次要结局
- Number of participants with treatment-related adverse events(At study visits 3 and 4, which are 3 months after the BoNT injection cycles with intervention OZS or placebo)
研究者
Padraig O'Suilleabhain
Professor of Neurology
University of Texas Southwestern Medical Center