NCT00693862已完成1 期
Levodopa Concentration Profile After Repeated Doses of Stalevo
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The purpose of this study is to show that higher minimum concentration values are obtained following repeated doses of Stalevo 4 times daily compared to lecodopa/carbidopa treatment with corresponding dosing regimen.
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
- 30 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained
- •Male or female patients with idiopathic Parkinson's disease with either a stable drug response or mild and predictable end-of-dose wearing-off symptoms.
- •Hoehn and Yahr stage 1-2.5 performed during the "ON" state.
- •Treatment with 3-5 daily doses of levodopa/DDCI ± entacapone with a total daily levodopa dose in the range of 300-600 mg.
- •Unchanged levodopa/DDCI ± entacapone and other antiparkinsonian medication (dopamine agonists, monoamine oxidase B (MAO-B) inhibitor, amantadine and/or anticholinergics with doses recommended by the manufacturer), if any, for at least 2 weeks prior to the first treatment period.
- •Age within 30-72 years, inclusive.
排除标准
- •Secondary or atypical parkinsonism.
- •Patients with moderate to marked wearing-off symptoms or any unpredictable "OFF"-periods.
- •Patients with treatment-related peak-dose dyskinesia.
- •Change in dose strength, daily dose or dosing frequency of any medicinal products used to treat other medical conditions than Parkinson's disease within 2 weeks.
- •Use of any iron preparations or other chelating agents.
- •Patients with a history of a laboratory abnormality consistent with, or clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness, which may influence the outcome of the study.
- •History of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis, malignant melanoma, narrow-angle glaucoma or pheochromocytoma.
- •Any abnormalities in laboratory values, vital signs or electrocardiogram (ECG) with clinical relevance.
- •Patients using any antiparkinsonian drugs for rescue medication (including soluble levodopa formulations).
- •Concomitant treatment with apomorphine, MAO-A inhibitors or non-selective MAO inhibitors.
- •Known hypersensitivity to active substances or to any of the excipients of the study drugs.
- •Participation in other drug studies within 60 days prior to study entry
- •Unsuitable veins for repeated venopuncture.
- •Blood donation or loss of significant amount of blood within 60 days prior to the screening.
研究组 & 干预措施
Stalevo
Experimental
干预措施: levodopa, carbidopa, entacapone (Drug)
levodopa/carbidopa
Active Comparator
干预措施: levodopa, carbidopa (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: Blood samples collected frequently on day 4 of both periods
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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