NCT03548194已完成2 期
A Phase II Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of BNC210 in Hospitalised Elderly Patients With Agitation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
研究概览
简要总结
This is a Phase II randomised, double-blind, placebo-controlled study assessing the effects of BNC210 on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS). Safety and tolerability of BNC210 will also be assessed.
The secondary objectives of the study include evaluation of the effects of BNC210 on global function in patients with agitation as assessed by the Clinical Global Impression Scale (CGI-S/I).
Participants will receive 5 days of blinded treatment followed by 2 days of follow up.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female elderly patient admitted to hospital and under the care of a specialist Geriatrician
- •Determined to have agitation requiring intervention in addition to standard of care behavioural management, as assessed by the Investigator or delegate, after at least 24 hours following admission to hospital.
排除标准
- •Severe Alzheimer's Dementia (stage 7) as assessed by the Functional Assessment Staging Test (FAST).
- •Diagnosed with Severe Parkinson's Disease.
- •Premorbid psychotic illness as assessed by the Investigator.
- •Evidence of severe organ dysfunction
- •Confirmed metastatic malignancy.
研究组 & 干预措施
BNC210
Experimental
Administered orally b.i.d. for 5 days.
干预措施: BNC210 (Drug)
Placebo
Placebo Comparator
Administered orally b.i.d. for 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Absolute change in agitation, as measured by the Pittsburgh Agitation Scale (PAS).
时间窗: 5 days
次要结局
- Proportion of participants reaching the "Non-Agitated" state(5 days)
- Time to first reach a "Non-Agitated" state.(5 days)
- Absolute change in global function, as measured by the Clinical Global Impression Scale - Severity and Improvement (CGI-S/I)(5 days)
研究者
研究点 (5)
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