NCT03542851Unknown2 期
A Randomized, Placebo-Controlled, Double-Blind, Crossover Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia
Balance Therapeutics32 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年5月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 32
- 主要终点
- The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
研究概览
简要总结
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.
详细描述
This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia (IH). The objectives of this study are two-fold: 1) To evaluate the efficacy of BTD-001 in subjects with IH as reflected by changes in cognitive, sleep, functional, and quality-of-life measures and 2) To characterize the safety and tolerability of oral BTD-001 administered to subjects with IH.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females age 18 to 70 years old
- •Onset of hypersomnia between age 10 and 30 years of age
- •An Epworth Sleepiness Scale score of greater than or equal to 11
- •Able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine (if on stimulants, agree to adhere to stable regimen throughout the trial)
- •Females with a negative pregnancy test AND who are non-lactating
- •Sexually active females of childbearing potential must be willing to use a highly effective method of birth control
- •Sexually active males must have a vasectomy or use condoms
排除标准
- •History of any disorder causing hypersomnia other than IH
- •Evidence of circadian-rhythm disorder
- •Sleep apnea syndrome
- •Use of CPAP
- •Obese subjects with BMI greater than or equal to 35kg/m2
- •History of or current seizure disorder or history of syncope, unexplained loss of consciousnesses or seizure in the past 3 years as well as any past history of benzodiazepine and/or barbiturate and/or alcohol-related withdrawal seizures
- •Columbia-Suicide Severity Rating Scale (C-SSRS) findings consistent with significant history of or current suicidal ideation or behavior
- •Subjects who fail to wash out medications for IH or any other prohibited medications
- •Positive toxicology screen test during the Screening or Baseline Visits.
- •Clinically significant abnormal findings from physical, electrocardiogram (ECG) or laboratory assessments at Screening
- •History of or current significant pulmonary, cardiac, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carinomas or local cervical squamous cell carcinoma resolved after resection) or hypothyroidism (unless euthyroid at Screening Visit and treated with a stable dose of medication for at least 3 months prior to the Baseline Visit).
- •Participation in a clinical drug trial within 4 weeks of Screening Visit
研究组 & 干预措施
Subject Receives BTD001 first
Experimental
干预措施: Pentetrazol (PTZ) (Drug)
Subject Receives BTD001 first
Experimental
干预措施: Placebo oral capsule (Drug)
Subject Receives Placebo first
Experimental
干预措施: Pentetrazol (PTZ) (Drug)
Subject Receives Placebo first
Experimental
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
The efficacy of BTD-001 in subjects with IH as reflected by the IH Symptom Diary
时间窗: Change from baseline.
Measurements: IH Symptom Diary.
次要结局
- The efficacy of BTD-001 in subjects with IH as reflected by changes in functional measures.(Change from baseline.)
- The efficacy of BTD-001 in subjects with IH as reflected by changes in sleep measures.(Change from baseline.)
研究者
研究点 (32)
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