Therapeutic Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Theranexus
- 入组人数
- 20
- 主要终点
- Sustained attention (PVT)
研究概览
简要总结
Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h).
Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PBO
Placebo
干预措施: Placebo (Drug)
MOD
Modafinil 100mg
干预措施: Modafinil (Drug)
THN102 100/1
modafinil 100 mg + 1 mg flecainide
干预措施: THN102 (Drug)
THN102 100/3
modafinil 100 mg + 3 mg flecainide
干预措施: THN102 (Drug)
THN102 100/9
modafinil 100 mg + 9 mg flecainide
干预措施: THN102 (Drug)
结局指标
主要结局
Sustained attention (PVT)
时间窗: 5 hours post treatment
Mean speed at the 10 min Psychomotor vigilance test (PVT)
次要结局
- Working memory(16,5 hours post treatment)
- Sustained attention (PVT) AUC(AUC of PVT speed during TSD)
- Mental flexibility(16,5 hours post treatment)
- Mental inhibition(16,5 hours post treatment)