NCT00736931已完成1 期
Randomized, Comparative, Double-blind, Placebo-controlled, Triple-dummy, Four-way Cross-over Study to Investigate Neurocognitive Effects of Brivaracetam in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 20
- 主要终点
- Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)
研究概览
简要总结
The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteer aged 18 to 50 years inclusive
- •Body Mass Index (BMI) between 18.0 and 30.0 kg/m² inclusive
- •Good physical and mental health status
- •Blood pressure and heart rate within normal range
- •Electrocardiogram and laboratory tests without clinically significant abnormality
排除标准
- •IQ ≤ 80 as determined by Test of non-verbal intelligence
- •Center for Epidemiological Studies Depression (CES-D Scale ≥16,
- •Known allergy/intolerance to pyrrolidinone derivatives
- •Abnormalities on EEG recordings
- •Pregnant, lactating women
- •History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, neurological, psychiatric disorders
- •Use of any hepatic enzyme-inducing drug
研究组 & 干预措施
1
Experimental
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
干预措施: Brivaracetam (Drug)
2
Active Comparator
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
干预措施: levetiracetam (Drug)
3
Active Comparator
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
干预措施: lorazepam (Drug)
4
Placebo Comparator
4 arms (in cross-over): brivaracetam, levetiracetam, lorazepam and placebo.
干预措施: placebo (Other)
结局指标
主要结局
Summary score from a Cognitive Neurophysiological Test (derived from electroencephalogram [EEG], event related potentials [ERP], and cognitive performance measures)
时间窗: 3 weeks
次要结局
- Component subscores from the Cognitive Neurophysiological Test and scores from neuropsychological tests/assessments: SSEQ Subject Self Evaluation Questionnaire. SMDT Symbol Digit Modalities Test. COWA Controlled Oral Word Association. MCG Parag(3 weeks)
研究者
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