A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 90
- 主要终点
- UPDRS parts II (averaged "on" and "off")
研究概览
简要总结
The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.
详细描述
This is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory of tesofensine versus placebo in levodopa treated Parkinson patients with motor fluctuations.
Patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50 mg or 1.0 mg) or with placebo, once daily, over 14 weeks.
The two co-primary efficacy endpoints are the change in off-time and the change in the Unified Parkinson Disease Rating Scale (UPDRS) II+III total score
Study Hypothesis:
The null hypothesis is that there is no difference between placebo and tesofensine.
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
- Double
入排标准
- 年龄范围
- 42 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
UPDRS parts II (averaged "on" and "off")
时间窗: 14 weeks
"Off" time during waking hours
时间窗: 14 weeks
次要结局
- Modified Schwab and England Disability scale(14 weeks)
- Snaith-Hamilton Pleasure Scale (SHAPS)(14 weeks)
- Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours(14 weeks)
- Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score(14 weeks)
- Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia(14 weeks)
- Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores(14 weeks)
- Clinical Global Impressions (CGI) Improvement and Severity(14 weeks)
- Auditory Verbal Learning test (AVLT)(14 weeks)