A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects 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
- 终止
- 入组人数
- 507
- 试验地点
- 1
- 主要终点
- Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy
研究概览
简要总结
Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man.
This is a double-blind, placebo-controlled, extension trial, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease.
The principal objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.
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
- Triple (Participant, Care Provider, Investigator)
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 subject completed 24 weeks of Trial
- •The subject successfully completed all trial requirements in Trial
- •If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, women of childbearing potential are defined as: "All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive".
- •Subject is willing and able to participate in the trial and has provided written, informed consent
排除标准
- •If female, the subject is pregnant or lactating.
- •The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
- •The subject has shown clinically significant deterioration during participation in Trial
- •Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
- •The investigator deems it is not in the subject's best interest to participate to trial 27938
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
研究组 & 干预措施
Arm 3
Placebo
干预措施: Placebo (Drug)
Arm 1
Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: Safinamide, MAO-B inhibitor (Drug)
Arm 2
Number of Cycles: until progression or unacceptable toxicity develops.
干预措施: Safinamide, MAO-B inhibitor (Drug)
结局指标
主要结局
Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy
时间窗: Week 78
次要结局
- Clinical Global impression (CGI) - Severity scale score change from baseline to week 78(Week 78)
- Proportion of subjects requiring intervention(Week 78)
- Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78(Week 78)
- Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78(Week 78)
- Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78(Week 78)
- EuroQoL 5D (EQ-5D) score change from baseline to week 78(Week 78)
- Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78(Week 78)
- Cogtest® PD battery test score change from baseline to week 78(Week 78)