Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Theranexus
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Epworth Sleepiness Scale (ESS)
研究概览
简要总结
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg, Modafinil/Flecainide 300 /27 mg).
详细描述
The 3 double blind periods (2-week) follow a stabilisation period for modafinil at 300 mg/day (open, 2-week) and are followed by a one-week washout period with the same modafinil dose.
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 65 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
研究组 & 干预措施
THN102 300/3
3 tablets modafinil 100 mg per day and 3 capsules flecainide 1 mg per day (THN102 as 300 + 3 mg) for 2 weeks
干预措施: THN102 300/3 (Drug)
THN102 300/27
3 tablets modafinil 100 mg per day and 3 capsules flecainide 9 mg per day(THN102 as 300 + 27 mg) for 2 weeks
干预措施: THN102 300/27 (Drug)
结局指标
主要结局
Epworth Sleepiness Scale (ESS)
时间窗: 14 days after the beginning of treatment period
Range 0 to 24, low score indicates good outcome
次要结局
- 14-item Fatigue Scale(14 days after the beginning of treatment period)
- Questionnaire EQ-5D (European Quality of Life EQ-5D) (Questionnaire Part)(14 days after the beginning of the screening)
- Patient Global Impression of Change (PGI-C)(14 days after the beginning of treatment period)
- Clinical Global Impression of Change (CGI-C) Global Impression(14 days after the end of treatment period I)
- Beck Depression Inventory (BDI)(14 days)
- Patient Global Impression for Severity (PGI-S) Global Score(14 days)
- Clinical Global Impression of Change (CGI-C) Sleepiness(14 days after the end of treatment period I)
- Clinical Global Impression of Change (CGI-C) Cataplexy(14 days after the end of treatment period I)
- Clinical Global Impression for Severity (CGI-S) Global Score(14 days after the end of treatment period I)
- Clinical Global Impression for Severity (CGI-S) Sleepiness(14 days after the end of treatment period I)
- Clinical Global Impression for Severity (CGI-S) Cataplexy(14 days after the end of treatment period I)
- EQ-5D European Quality of Life EQ-5D (Visual Analogic Scale Part)(14 days)