A Phase 2, Long-term Extension Study of the Safety and Efficacy of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored ORX750 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 25
- 主要终点
- Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
研究概览
简要总结
This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1)
- •Is willing and able to adhere to additional protocol requirements
排除标准
- •Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study
- •Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia
研究组 & 干预措施
Narcolepsy Type 1
Narcolepsy Type 1 (Open Label)
干预措施: ORX750 (Drug)
Narcolepsy Type 2
Narcolepsy Type 2 (Open Label)
干预措施: ORX750 (Drug)
Idiopathic Hypersomnia
Idiopathic Hypersomnia (Open Label)
干预措施: ORX750 (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
时间窗: Up to day 70
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Abnormal Laboratory Tests
时间窗: Up to day 70
Number of Participants With Abnormal Changes From Baseline in Laboratory Tests
Abnormal Vital Signs
时间窗: Up to day 70
Number of Participants With Abnormal Change From Baseline in Vital Signs
Abnormal ECG
时间窗: Up to day 70
Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)
Suicidal Ideation or Behavior
时间窗: Up to day 70
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
次要结局
- Tmax(Up to day 63)
- Cmax(Up to day 63)
- AUClast(Up to day 63)
- Cmax,ss(Up to day 63)
- AUCτ(Up to day 63)
- Maintenance of Wakefulness Test(Up to day 63)
- Epworth Sleepiness Scale(Up to day 63)