Placebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 363
- 主要终点
- 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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.
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.
详细描述
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 40mg/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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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 >=300mg of levodopa 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.
- •Be at least 20 years of age.
- •Be willing and able to give written informed consent.
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 25 or less.
- •History of drug or alcohol abuse or dependence within the past two years.
- •History of psychosis.
- •Significant drug allergies.
- •Taking anticonvulsants for seizures.
- •History of neurological malignant syndrome.
- •Pregnant or lactating females.
研究组 & 干预措施
1
20 mg KW-6002 per day (two 10 mg tablets orally once daily for 12 weeks)
干预措施: Istradefylline (Drug)
2
40mg KW-6002 per day (two 20 mg KW-6002 tablets orally once daily for 12 weeks)
干预措施: Istradefylline (Drug)
3
Two placebo tablets once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
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 Parkinson's disease (PD) treated with levodopa/dopa-decarboxylase inhibitor.
时间窗: Last Visit
次要结局
- To evaluate the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean percentage of awake time per day spent in the OFF state.(Every Visit)
- To evaluate 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).(Every Visit)
- To evaluate the change in Unified Parkinson's Disease Rating Scale (UPDRS).(Every Visit)
- To evaluate change in the Clinical Global Impression - Improvement scale (CGI-I).(Visit 4 and Last Visit)
- To evaluate the safety of 20 mg/day and 40mg/day doses of istradefylline(Every Visit)