Is Long-term Use of Amantadine Effective in Parkinson Disease?
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
研究概览
简要总结
The investigator aims to assess whether long-term use of amantadine is effective in patients with Parkinson's disease.
详细描述
Amantadine is used in the early stages of Parkinson's disease (PD). However, amantadine is known to be relatively weak compared to other antiparkinsonian drugs such as levodopa, dopamine agonist or Mao-B inhibitor and its effects are limited in early months, so it is rarely used than other drugs.
Recently, several studies have identified the long-term effects of amantadine on dyskinesia, but the basis is still insufficient.
Therefore, this study aims to investigate the long-term effectiveness of amantadine in patients with PD. Participants who have used amantadine since the early stages of diagnosis undergo clinical evaluations including the Montreal Cognitive Assessment (MoCA), Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Freezing of Gait-Questionnaire (FOG-Q), Non-motor Symptom Scale (NMSS) and Parkinson's Disease Questionnaire-39 (PDQ-39). Then, participants stop taking amantadine. To investigate the long-term effect, clinical evaluations except MoCA are repetitively assessed at 4- and 8-week follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have been taking amantadine since the beginning of diagnosis
- •Patients who have taken amantadine for more than five years
- •Patients with Parkinson's disease who are aged 40 years or older
排除标准
- •Patient who stops amantadine or is hypersensitive to amantadine
- •Patients who have undergone brain surgery, including deep brain stimulation
- •Patient identified as atypical parkinsonism
- •Patients with psychiatric conditions such as dementia, major depression or bipolar disorder who are difficult to assess
- •Patients who are currently unable to follow up at our hospital
研究组 & 干预措施
PD patients who have taken amantadine
干预措施: Determination of drug effects through amantadine cessation (Drug)
结局指标
主要结局
Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
时间窗: Baseline, 4 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 132\]
Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score
时间窗: Baseline, 8 weeks
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III score will be used to determine the efficacy of amantadine. Higher scores mean a worse outcome. \[minimum 0, maximum 132\]
次要结局
- Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score(Baseline, 8 weeks)
- Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score(Baseline, 4 weeks)
- Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score(Baseline, 8 weeks)
- Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score(Baseline, 4 weeks)
- Change from baseline to 4-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score(Baseline, 4 weeks)
- Change from baseline to 8-week f/u in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score(Baseline, 8 weeks)
- Change from baseline to 4-week f/u in Hohr and Yahr stage score(Baseline, 4 weeks)
- Change from baseline to 8-week f/u in Hohr and Yahr stage score(Baseline, 8 weeks)
- Change from baseline to 4-week f/u in Freezing of Gait Questionnaire score(Baseline, 4 weeks)
- Change from baseline to 8-week f/u in Freezing of Gait Questionnaire score(Baseline, 8 weeks)
- Change from baseline to 4-week f/u in Parkinson's Disease Questionnaire-39 score(Baseline, 4 weeks)
- Change from baseline to 8-week f/u in Parkinson's Disease Questionnaire-39 score(Baseline, 8 weeks)
- Change from baseline to 4-week f/u in Non-motor Symptom Scale score(Baseline, 4 weeks)
- Change from baseline to 8-week f/u in Non-motor Symptom Scale score(Baseline, 8 weeks)
研究者
BS Jeon
Professor
Seoul National University Hospital