NCT01286935已完成3 期
A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic
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
- 544
- 主要终点
- Mean change in the dyskinesias rating scale (DRS) during "on" time
研究概览
简要总结
The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.
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
- •The patient completed 24 weeks of treatment in Study 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
- •The patient was compliant with taking study medication in Study
- •The patient is willing to participate in the study and signed an approved Informed Consent form.
排除标准
- •The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
- •The patient has shown clinically significant deterioration during participation in Study 016, and has reached Hoehn and Yahr Stage V.
- •The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.
研究组 & 干预措施
Low Dose (50mg/day)
Experimental
干预措施: Safinamide (Drug)
High Dose (100mg/day)
Experimental
干预措施: Safinamide (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in the dyskinesias rating scale (DRS) during "on" time
时间窗: Up to 104 weeks (from baseline 016 to EOS study 018)
mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).
次要结局
- Endpoints include 'ON time', responder rates and UPDRS IV change(Up to 104 weeks (from baseline 016 to EOS study 018))
研究者
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