NCT06767683招募中2 期
An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 50
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
- •Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)
排除标准
- •Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
- •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
Narcolepsy Type 2 (NT2)
Experimental
干预措施: ALKS 2680, 18mg (Drug)
Idiopathic Hypersomnia (IH)
Experimental
干预措施: ALKS 2680, 10mg (Drug)
Idiopathic Hypersomnia (IH)
Experimental
干预措施: ALKS 2680, 14mg (Drug)
Idiopathic Hypersomnia (IH)
Experimental
干预措施: ALKS 2680, 18mg (Drug)
Narcolepsy Type 1 (NT1)
Experimental
干预措施: ALKS 2680, 4mg (Drug)
Narcolepsy Type 1 (NT1)
Experimental
干预措施: ALKS 2680, 6mg (Drug)
Narcolepsy Type 1 (NT1)
Experimental
干预措施: ALKS 2680, 8mg (Drug)
Narcolepsy Type 2 (NT2)
Experimental
干预措施: ALKS 2680, 10mg (Drug)
Narcolepsy Type 2 (NT2)
Experimental
干预措施: ALKS 2680, 14mg (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Up to 100 Weeks
次要结局
- Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)(Baseline to Week 24)
- Change in Epworth Sleepiness Scale (ESS)(Baseline to 96 Weeks)
研究者
研究点 (50)
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