NCT00986414已完成2 期
13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 260
- 试验地点
- 8
- 主要终点
- Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
研究概览
简要总结
This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
排除标准
- •Surgical treatment for PD
- •Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
- •Advanced, severe or unstable disease (other than PD) that may interfere with the study outcome evaluations
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
AFQ056-75mg
Experimental
干预措施: AFQ056 (Drug)
AFQ056-100mg
Experimental
干预措施: AFQ056 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
AFQ056-10mg
Experimental
干预措施: AFQ056 (Drug)
AFQ056-25mg
Experimental
干预措施: AFQ056 (Drug)
AFQ056-50mg
Experimental
干预措施: AFQ056 (Drug)
结局指标
主要结局
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
时间窗: 12 weeks
次要结局
- Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)(12 weeks)
- Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD(12 weeks)
- Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change(12 weeks)
- Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score(12 weeks)
研究者
研究点 (8)
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