A Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change of FOGQ score
研究概览
简要总结
Tp determine the effect of IV amantadine on dopaminergic-drug-resistant freezing of gait(FOG)in patients with Parkinson's disease
详细描述
- Freezing of gait (FOG) is one of the most disabling symptoms of Parkinson's disease.
We experienced that severe FOG was markedly improved by IV amantadine in the patients who had Parkinson's disease. But IV drug may have placebo effect. Therefore, We designed double blind, placebo controlled study to know whether IV amantadine is effective in the patient with dopaminergic-drug-resistant freezing of gait(FOG). 2. Cross over study design
- Compare the change of FOGQ(freezing of gait questionaire) score from the baseline to IV amantadine and placebo drug
- randomized assigned order of amantadine and placebo drug.
- investigator of FOG: blinded to the order of drugs
- each patient has IV drug for 2 days for each drug
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •"Off" freezing:The patient has improved FOG in "On" state
- •clinically significant or unstable medical or surgical condition
- •The patient has Parkinson plus like MSA, PSP, and PPFG, and secondary parkinsonism like NPH, vascular parkinsonism, postencephalitic parkinsonism, CO poisoning.
- •history of seizure.
研究组 & 干预措施
Group 1
Give IV amantadine first then IV placebo(normal saline) drug
干预措施: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj (Drug)
Group 2
Give IV placebo drug first then IV amantadine
干预措施: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj (Drug)
结局指标
主要结局
change of FOGQ score
时间窗: 2 days for each drug
次要结局
- UPDRS and HY stage(2 days for each drug)
- side effect(2 days, 2 weeks after discharge)
- Patient global impression(2 days, 2 weeks after discharge)
- 4*10m walk test(2 days for each drug)
研究者
BS Jeon
Professor
Seoul National University Hospital