NCT01058291已完成3 期
Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- The raw score change in UPDRS part III score
研究概览
简要总结
This is a placebo-controlled double-blind crossover comparative study of KW-6500 in Parkinson's disease patients with motor response complications on levodopa therapy. The efficacy of KW-6500 is evaluated using the change of UPDRS part III score at double blind period after 12 weeks subcutaneous self-injections.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given written informed consent
- •Patients who have Parkinson's disease
- •Patients who have been on a stable regimen of levodopa plus at least one other antiparkinsonian agent and who have OFF state
- •Patients who meet stage 4 or 5 while in the OFF state and stage 0 to 3 while in the ON state on the Modified Hoehn and Yahr Scale
- •Patients who have experienced a 30% or more improvement in Unified Parkinson's Disease Rating Scale (UPDRS) partⅢ score when tested for responsiveness to levodopa during the baseline period
- •Patients who have at least one OFF state per day
- •Patients who can understand the expression of OFF state, ON state, and dyskinesia
- •Patients or their families have a desire for self-injection of KW-6500
排除标准
- •Patients with an illness of the cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system (excluding Parkinson's disease)
- •Patients with orthostatic hypotension
- •Patients with a history of intolerance to morphine or its derivatives, sulfur, sulfur-containing pharmaceutical products, or sulfite
- •Patients with a history of malignant syndrome
- •Patients with a diagnosis of cancer or evidence of continued disease
- •Patients who do not test negative in the direct Coombs' test
- •Pregnant or lactating women, women who are planning to have children, women who test positive in the pregnancy test, or women who cannot adhere to a reliable method of contraception
- •Patients who have received MAO inhibitors except selegiline
- •Patients with a history of mental disease (excluding psychiatric symptoms associated with Parkinson's disease)
- •Patients with a Mini-Mental State Examination score of 23 or less
- •Patients who are taking antipsychotics or central dopamine antagonists (excluding domperidone)
- •Patients who are receiving methyldopa or 5-HT3 receptor antagonists
- •Patients who are receiving reserpine or papaverine
- •Patients who have had a neurosurgical operation for Parkinson's disease
- •Patients who have had transcranial magnetic stimulation
- •Patients with a history of drug or alcohol abuse or dependence
研究组 & 干预措施
KW-6500
Experimental
干预措施: KW-6500 (Drug)
KW-6500 Placebo
Placebo Comparator
干预措施: KW-6500 Placebo (Drug)
结局指标
主要结局
The raw score change in UPDRS part III score
时间窗: At the double blind period
次要结局
- The percent score change in UPDRS part III score and response ratio(At the double blind period)
研究者
研究点 (1)
Loading locations...
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