Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 4
- 主要终点
- Modified AIMS
研究概览
简要总结
The study is designed to measure the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in late-stage Parkinson's disease. The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.
详细描述
The LeLeDys study is designed to determine the efficacy and safety of levetiracetam on levodopa-induced dyskinesias in advanced Parkinson's disease.
The design is a multicenter, randomized, stratified, double-blinded, placebo-controlled phase IV study design.
The hypothesis is that levetiracetam is able to reduce duration and severity of levodopa-induced dyskinesias in Parkinson's disease.
The patients are planned to be treated with levetiracetam (up to 2000 mg per day) or placebo for 13 weeks. Efficacy measure is the modified AIMS.
Main inclusion criteria are:
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
- Double (Participant, 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
- •Advanced Parkinson's disease (Hoehn & Yahr II-IV)
- •Age of 30 to 80 years
- •Levodopa-induced dyskinesias of at least 25% of the waking day and with moderate disability
- •Stable dosage of antiparkinson medication and/or stable deep brain stimulation parameters for at least 4 week prior inclusion
- •Written informed consent
排除标准
- •Atypical parkinsonian syndromes
- •Treatment with antipsychotics
- •Epilepsia or seizure in the history
- •Deep brain stimulation other than DBS in STN
- •Pregnant or lactating women
- •Severe dementia
结局指标
主要结局
Modified AIMS
时间窗: 11 weeks
UPDRS items 32 & 33
时间窗: 11 weeks
次要结局
- UPDRS(11 weeks)
- Schwab & England scale(11 weeks)
- Hoehn & Yahr scale(11 weeks)
- GCI(11 weeks)
- Patient day record(11 weeks)
- Epsworth sleep scale(11 weeks)
- Levodopa challenge test(11 weeks)
- Safety measures(11 weeks)