Randomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- changes in scores on Freezing of Gait Questionnaire
研究概览
简要总结
A double-blinded randomized placebo-controlled trial of intravenous amantadine on gait freezing refractory to oral anti-parkinsonian medications in patients with Parkinson's disease.
- administration of IV amantadine or normal saline for 5 days, 2 times a day while keeping current oral anti-parkinsonian medications unchanged
- follow-up after administration of IV amantadine for 4 weeks
- allocation ratio of amantadine:normal saline is 2:1
详细描述
Intravenous amantadine is known to be effective for parkinsonian motor symptoms abruptly aggravated and for disabling motor symptoms from severe motor fluctuation and dyskinesia in patients with Parkinson's disease. The study investigators experienced several open label cases who were benefit from intravenous amantadine in their parkinsonian motor symptoms and freezing of gait as well. In addition, there is a pilot open label trial in parkinsonian patients with refractory freezing of gait which showed marked benefit in patients with Parkinson's disease, but not in patients with parkinson-plus syndromes.
This study was aimed to evaluate the efficacy of intravenous amantadine in both levodopa-unresponsive freezing of gait and disabling off state freezing of gait in patients with Parkinson's disease.
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
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the diagnosis of Parkinson's disease according to the United Kingdom Parkinson's Disease Brain Bank criteria
- •presence of freezing of gait and the scores of Freezing of Gait Questionnaire 7 or more
- •having been treated with oral dopamine replacement therapy for 6 months or more
- •score of Korean version of mini-mental status examination is 20 or more
排除标准
- •presence of significant cognitive dysfunction, behavioral or psychiatric disorders
- •presence of severe cardiac disease
- •presence of renal failure, seizure, peptic ulcer disease, liver disease, pheochromocytoma, chronic exhaustive disease, or malignancy
- •participation to other clinical trial within 4 weeks
- •pregnancy or lactating women
- •hypersensitivity to study drugs
- •history of intoxication to heavy metals
研究组 & 干预措施
amantadine
administration of intravenous amantadine sulfate 200mg/500ml/bottle 1 bottle infusion over 3 hours, twice a day for consecutive 5 days
干预措施: amantadine sulfate (Drug)
placebo
administration of 0.9% sodium chloride 500ml/bottle 1 bottle infusion over 3 hours twice a day for consecutive 5 days
干预措施: 0.9% sodium chloride (Drug)
结局指标
主要结局
changes in scores on Freezing of Gait Questionnaire
时间窗: after completion of 5-day schedule of IV amantadine treatment compared with baseline status
次要结局
- changes in scores on Freezing of Gait Questionnaire(after 4-weeks of follow-up compared with baseline status)
- changes of scores on the Unified Parkinson's disease Rating Scale Part III(after completion of IV amantadine treatment compared with baseline status)
- changes of scores on the Unified Parkinson Disease Rating Scale Part III(after 4- weeks of follow-up compared with baseline status)
研究者
Jee-Young Lee
assistant professor
Seoul National University Hospital