A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 613
- 试验地点
- 4
- 主要终点
- Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
研究概览
简要总结
This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 years of age or older.
- •UK Parkinson's Disease Society (UKPDS) brain bank criteria (Step 1 and 2) for PD
- •PD Stages 2-4 in the ON state for Modified Hoehn and Yahr Scale.
- •On levodopa therapy for at least 1 year with beneficial clinical response at the baseline visit
- •Taking at least 400mg levodopa combination daily and on stable regimen of any other anti-Parkinsonian drugs (MAO-B, COMT, DA) for at least 2 weeks prior to randomization
- •Stable dopaminergic regimen for at least 4 weeks immediately prior to randomization
- •Documented end-of-dose wearing-off and levodopa-induced dyskinesia
- •Have an average of two hours of OFF time per day
排除标准
- •Subjects on apomorphine and/or dopamine receptor antagonists or direct gastrointestinal levodopa infusion.
- •Subject who have had neurosurgical operation for PD
- •Subjects taking A2a antagonist, potent CYP3A4 inhibitors, potent CYP34A inducers
- •Subjects who smoke > 5 cigarettes/day
研究组 & 干预措施
Istradefylline 20 mg/day
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
干预措施: Istradefylline 20 mg (Drug)
Istradefylline 20 mg/day
Istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
干预措施: Placebo (Drug)
Istradefylline 40 mg/day
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
干预措施: Istradefylline 40 mg (Drug)
Istradefylline 40 mg/day
Istradefylline 40 mg and placebo to match istradefylline 20 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
干预措施: Placebo (Drug)
Placebo
Placebo to match istradefylline 20 mg and placebo to match istradefylline 40 mg:
A daily, oral, double-blind treatment dose of both tablets will be taken in the morning for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
时间窗: Baseline, Week 2, Week 6, Week 10 and Week 12.
Based on the 24-hour ON/OFF patient diary data.
次要结局
- Total Hours of ON Time Per Day Without Troublesome Dyskinesia(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Unified Parkinson's Disease Rating Scale (UPDRS) Motor Examination Score (Part III);(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Unified Parkinson's Disease Rating Scale (UPDRS) Activities of Daily Living (ADL) Score (Part II)(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Unified Parkinson's Disease Rating Scale (UPDRS Mentation, Behaviour) and Mood (Part I)(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Total UPDRS (Parts I + II + III);(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Patient Global Impression - Improvement (PGI-I) Scale(Baseline, Week 2, Week 6, Week 10, Week 12 and 30-day FU visit)
- Sleep Time in Hours Per Day Based Upon 24-hour Diaries.(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Percentage of Awake Time Per Day Spent in the OFF State(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Percentage of ON Time Per Day Without Troublesome Dyskinesia.(Baseline, Week 2, Week 6, Week 10 and Week 12.)
- Montreal Cognitive Assessment (MoCA)(Baseline and Week 12.)
- Beck Depression Inventory (BDI)(Baseline and Week 12.)