Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in the time to ON after first morning dose using 3-day PD diary
研究概览
简要总结
The purpose of this study is to determine whether levodopa/benserazide dispersible is effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.
详细描述
Delayed ON is one of the motor complications of advanced PD patients that effect of anti-parkinsonian medication is delayed more than 40 minutes after intake. In the most severe cases, the effect does not appear even until next medication schedule, so called "No ON" status. It is important to manage delayed ON properly because it can interfere motor functions and quality of life of PD patients.
Levodopa/benserazide dispersible can be absorbed rapidly in the intestine, so theoretically it can break the poor response to conventional treatment of PD patients with delayed ON. However, this has not been proven by clinical trials till now.
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
- None
入排标准
- 年龄范围
- 31 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 31 and 80 years
- •Parkinson disease (PD) was diagnosed by United Kingdom Parkinson disease brain bank criteria
- •Patients receiving stable Levodopa treatment at least 2 weeks prior to baseline visit
- •Delayed ON was confirmed by a specialized PD diary that records change in motor symptoms 90 minute after the first morning dose. Delayed ON is defined as delay of more than 40 minutes after the first morning dose for resolution of OFF state or experience of no ON state at least 1 per week.
排除标准
- •Existence of cognitive decline hard to participate in the clinical trial or K-Minimental Status Exam score 24 or less
- •Any contraindication of blood sampling
- •Subjects with clinically significant psychiatric illness
- •Subjects with a cancer or severe medical illness
- •Lactating, pregnant, or possible pregnant
- •History of malignant melanoma
- •Subjects with narrow-angle glaucoma
- •Subjects with hypersensitivity to levodopa or benserazide
- •Subjects treated with non-selective monoamine oxidase (MAO)-B inhibitors
- •Subjects with peptic ulcer, colitis, or gastrointestinal disease
研究组 & 干预措施
Levodopa dispersible
Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
干预措施: Levodopa dispersible (Drug)
Levodopa
Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
干预措施: Levodopa (Drug)
结局指标
主要结局
Change in the time to ON after first morning dose using 3-day PD diary
时间窗: 4 weeks
A specialized 3-day PD diary will be distributed to the patients 3 days prior to each visit. This diary will evaluate the latency of ON after intake of the study medication.
次要结局
- Change in the The Unified Dyskinesia Rating Scale (UDyskRS)(4 weeks)
- Change in the The Unified Parkinson Disease Rating Scale (UPDRS)(4 weeks)
- Change in the Total ON time, total OFF time using 3-day PD diary(4 weeks)
- Change in the The Schwab & England Activity of daily living scale (SEADL)(4 weeks)
- Change in the The Parkinson Disease Questionnaire-39 (PDQ-39)(4 weeks)
- Change in the Clinician global improvement (CGI)(4 weeks)
- Change in the Patient global improvement (PGI)(4 weeks)
- Change in the K-Minimental status examination (K-MMSE)(4 weeks)
研究者
Jee-Young Lee
Clinical Professor
Seoul National University Hospital