A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 227
- 主要终点
- Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur
研究概览
简要总结
To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.
详细描述
The study will consist of 12 months of double-blind treatment. Patients will continue to take the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).
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 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) 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
- •The patient discontinued Study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) in Study 015.
研究组 & 干预措施
High Dose
150-200mg/day
干预措施: Safinamide (Drug)
Low dose
50-100mg/day
干预措施: Safinamide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur
次要结局
未报告次要终点