Helicobacter Pylori Eradication and Motor Fluctuations in Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- "Off" Time
研究概览
简要总结
The purpose of this study is to determine whether treatment of H. pylori (an infection of the stomach) improves treatment effectiveness in patients with Parkinson's disease and motor fluctuations.
详细描述
Previous investigations have demonstrated that treatment of Helicobacter pylori with antibiotics leads to improved absorption and pharmacokinetics of levodopa. This may potentially benefit patients with Parkinson's disease who have motor fluctuations, specifically excessive "off" time, when their levodopa is not working to control symptoms. We seek to identify the frequency of H. pylori infection in this population using standard lab assays and determine whether eradication with standard triple therapy results in improved clinical response to medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 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
Active-placebo
These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
干预措施: clartihromycin, amoxicillin, and omeprazole (Drug)
Active-placebo
These subject receive treatment with active triple therapy followed by treatment with placebo therapy.
干预措施: placebo (Drug)
Placebo-active
These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
干预措施: clartihromycin, amoxicillin, and omeprazole (Drug)
Placebo-active
These subject receive treatment with placebo therapy followed by treatment with active triple therapy.
干预措施: placebo (Drug)
结局指标
主要结局
"Off" Time
时间窗: 2 months
Average total daily "off" time (measured by patient symptom diaries) in hours
次要结局
- Improvement in UDPRS Part III(2 months)
- Improvement in UPDRS Total Scores(2 months)
- Improvement in Quality of Life as Assessed by PDQ-39(2 months)
- Participants With Side Effects From Study Treatment(2 months)
研究者
Jeff Bronstein
Professor of Neurology
University of California, Los Angeles