NCT00505843已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's Disease
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
- 18
- 主要终点
- Efficacy will be assessed for up to 8 hours by the Unified Parkinson's Disease Rating Scale-Motor Examination and a modified AIMS dyskinesia scale
研究概览
简要总结
In this clinical trial, the safety of MK0657 when given with levodopa will be assessed in patients with Parkinson's Disease. This study will also measure the effectiveness of MK0657, when given in combination with levodopa, to improve motor symptoms and ameliorate dyskinesias (uncontrolled movements of a part of the body) as compared to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's Disease patients between the ages of 40 and 80 inclusive
- •Patient is in general good health based on screening assessments
- •Patient is willing to discontinue anti-parkinson's medications at least 8 hours prior to dosing
- •Patient is levodopa responsive with levodopa-induced peak-dose dyskinesias
- •Patient taking selective serotonin inhibitors (SSRIs), sleep medications and neuroleptics, have been on a stable dose for at least 30 days and has not experienced any CNS-related side effects
- •Patient is not a heavy smoker or drinker
排除标准
- •Patient has atypical Parkinson's syndrome due to drugs, identified metabolic and/or neurologic disorders, encephalitis, or other degenerative syndrome
- •Patient has known intolerance or hypersensitivity to levodopa or carbidopa
- •Patient has been on anticholinergics or memantine within 30 days prior to dosing
- •Patients have a history of the following: seizure disorder, stroke or head trauma, pronounced cognitive impairment, psychiatric disorder, cardiovascular disease, cancer, diabetes as defined by HbA1c of greater than 8%
- •Patient has a systolic BP or less than 80 mm Hg or greater than 150 mm Hg
研究组 & 干预措施
1
Other
7mg MK0657 capsules + >/=1.0 mg/kg/hr dose of levodopa.
干预措施: MK0657 (Drug)
结局指标
主要结局
Efficacy will be assessed for up to 8 hours by the Unified Parkinson's Disease Rating Scale-Motor Examination and a modified AIMS dyskinesia scale
时间窗: 45 Days
次要结局
- Safety and Tolerability(45 Days)
研究者
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