A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 51
- 主要终点
- Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level
研究概览
简要总结
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
- •Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years
排除标准
- •Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
- •Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
- •Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
- •Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
研究组 & 干预措施
Placebo- Part A
Oral placebo tablet for once daily administration
干预措施: Placebo (Drug)
Placebo - Part B
Oral tablets of placebo taken, orally, daily
干预措施: Placebo (Drug)
ALKS 2680, 10 mg- Part A
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
干预措施: ALKS 2680 (Drug)
ALKS 2680, 14 mg -Part A
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
干预措施: ALKS 2680 (Drug)
ALKS 2680, 18 mg- Part A
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
干预措施: ALKS 2680 (Drug)
ALKS 2680 Dose 1- Part B
Oral tablets of ALKS 2680 taken, orally, daily
干预措施: ALKS 2680 (Drug)
结局指标
主要结局
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level
时间窗: Up to 8 weeks
次要结局
- Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level(Up to 8 weeks)
- Incidence of treatment emergent adverse events(Up to 10 weeks)