A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)
研究概览
简要总结
The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •18-70 years of age
- •Has a BMI ≥18 and ≤40 kg/m2
- •Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.
- •Additionally, meets the following criteria:
- •Has residual excessive daytime sleepiness
- •Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
- •Is willing to adhere to additional protocol requirements
排除标准
- •Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
- •Is currently pregnant, breastfeeding, or planning to become pregnant during the study
- •Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening
研究组 & 干预措施
ALKS 2680, 10 mg
Oral tablet containing 10mg of ALKS 2680 for once daily administration
干预措施: ALKS 2680 (Drug)
ALKS 2680, 14 mg
Oral tablet containing 14mg of ALKS 2680 for once daily administration
干预措施: ALKS 2680 (Drug)
ALKS 2680, 18 mg
Oral tablet containing 18mg of ALKS 2680 for once daily administration
干预措施: ALKS 2680 (Drug)
Placebo
Oral tablet containing matching placebo for once daily administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)
时间窗: Baseline to Week 8
Change in Epworth Sleepiness Scale (ESS)
时间窗: Baseline to week 8
Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.
次要结局
- Incidence of adverse events(Up to 21 weeks)