NCT00955526已完成3 期
Placebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
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
- 373
- 主要终点
- Reducing the mean total hours of awake time per day spent in the OFF state
研究概览
简要总结
The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.
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
- •Be willing and able to give written informed consent
- •UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
- •PD stages 2-4 in the OFF state for Modified Hoehn and Yahr Scale
- •On levodopa/dopa-decarboxylase inhibitor for at least one year
- •Taking at least three doses and >=300 mg of levodopa/dopa-decarboxylase inhibitor per day for at least four weeks before randomization
- •Predictable end of dose wearing off
- •Able to satisfactorily complete Hauser based 24-hour patient Parkinson's diary
- •Have an average of two hours of OFF time on 24-hour diaries
- •On a stable regimen of any other anti-Parkinson's drugs for at least four weeks before randomization
- •On a stable dose of domperidone for at least 14 days before randomization
排除标准
- •Taking any excluded medications
- •Neurosurgical treatment or Transcranial Magnetic Stimulation for PD
- •Diagnosis of cancer within 5 years
- •Diagnosis of clinically significant illness of any organ system
- •Diagnosis of dementia or mini-mental status examination score of 23 or less
- •History of drug or alcohol abuse or dependence within the past two years
- •History of psychosis
- •History of significant drug allergies
- •Taking anticonvulsants for seizures
- •History of neuroleptic malignant syndrome
- •Pregnant or lactating females
研究组 & 干预措施
Istradefylline 20mg
Experimental
干预措施: Istradefylline (Drug)
Istradefylline 40mg
Experimental
干预措施: Istradefylline (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Reducing the mean total hours of awake time per day spent in the OFF state
次要结局
- Change in Unified Parkinson's Disease Rating Scale (UPDRS)
- Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
- Adverse events
- Reducing the mean percentage of awake time per day spent in the OFF state
- Change in the Clinical Global Impression - Improvement scale (CGI-I)
研究者
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