TCTR20180320005尚未招募3 期
Efficacy of Sublingual Administration of Atropine Solution for Drooling in Patient with Parkinson’s Disease: A randomized, double-blind, placebo-controlled, crossover study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- one
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria included patients diagnosed with Parkinson’s disease(PD) according to United Kingdom Parkinson’s Disease Society Brain Bank (UKPDS-BB) criteria by neurologists, age more than 17 years, suffering from drooling which was evaluated by Movement Disorders Society - United Parkinson’s Disease Rating Scale (MDS-UPDRS) part II: item 2.2; salivation and drooling subscore more than 1 score. The patients have not been received 1% atropine solution before, had the stable regimen of PD medications or stable Deep Brain Stimulation(DBS) setting in case of having the device for the preceding 2 weeks, and no changes were to be made to other antiparkinsonian medication doses or DBS setting during this study
排除标准
- •Exclusion criteria for the trial included the patients who had drooling from other causes such as dental problem, active hallucinations or psychosis, cardiovascular disease and, or cardiac arrhythmia, history of Botulinum toxin injection to salivary gland, active treatment with an anticholinergic drug. The patients getting pregnant or lactating women, diagnosed with Parkinson’s disease with dementia.
研究者
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