NCT02512588已完成2 期
A Randomized, Placebo-Controlled, Double-blind, Fixed-Dose, Multiple Cohort, Multiple Crossover, Dose-Finding Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2
Balance Therapeutics23 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 23
- 主要终点
- Efficacy Epworth Sleepiness Scale
研究概览
简要总结
This is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral BTD-001 in adult patients with IH or Narcolepsy without cataplexy (Type 2).
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
- Double (Participant, Investigator)
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
- •Meets ICSD-3 criteria for IH or Narcolepsy Type 2 and not undergoing pharmacologic treatment for the condition
- •Usual nightly total sleep at least 6 hours as single major rest period without naps
- •Epworth Sleepiness Scale of 10 or greater
- •Males or females age 18 to 65 years
排除标准
- •Any disorder causing hypersomnia other than IH or Narcolepsy Type 2
- •Usual bedtime later than midnight
- •Seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years
- •Beck Depression Inventory score greater than 19
- •Beck Anxiety Inventory score greater than 15
- •Significant history of or current suicidal ideation or behavior
- •BMI less than 18 kg/m2 or greater than 39 kg/m2
- •Positive toxicology screen or breathalyzer test
- •Clinically significant abnormal findings on safety assessments
- •Any significant medical or psychiatric disease or any condition that would put the patient at risk by participating in the study
研究组 & 干预措施
Placebo
Experimental
干预措施: Placebo (Drug)
BTD-001
Experimental
干预措施: BTD-001 (Drug)
结局指标
主要结局
Efficacy Epworth Sleepiness Scale
时间窗: After 14 days per treatment
Epworth Sleepiness Scale
次要结局
- Efficacy Maintenance of Wakefulness Test(After 14 days per treatment)
研究者
研究点 (23)
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