jRCT2031230135招募中不适用
A Long-term Extension Study to Evaluate the Safety and Tolerability of TAK-861 in Participants With Selected Central Hypersomnia Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 主要终点
- Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 16age old over 至 70age old under（—）
- 性别
- All
入选标准
- •Participant with a diagnosis of NT1 who has completed a controlled study with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
排除标准
- •Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the study drug from the parent study or discontinued because of TEAEs in the parent study.
- •Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- •The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values >1.5 times the upper limit of normal (ULN).
- •Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS).
- •Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months.
- •Participant has developed (within the last 6 months) gastrointestinal
- •disease that is expected to influence the absorption of drugs.
- •Participant has epilepsy or history of seizure.
- •Participant has any other medical condition, such as anxiety, depression, heart disease, or significant hepatic, pulmonary, or renal disease, that requires them to take excluded medications.
- •Participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), or cerebral hemorrhage.
- •Participant has a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- •Participant has a history of cancer in the past 5 years.
结局指标
主要结局
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
时间窗: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
次要结局
- Change from Baseline in the Parent Study in Mean Sleep Latency from the Maintenance of Wakefulness Test (MWT)(Baseline (parent study), Week 26 (current long-term extension [LTE] study))
- Change from Baseline in the Parent Study in Weekly Cataplexy Rate (WCR) Using the Patient-reported Cataplexy Diary(Baseline (parent study); Year 1 through Year 5 (current LTE study))
- Change from Baseline in the Parent Study in Epworth Sleepiness Scale (ESS) Total Score(Baseline (parent study); Week 2 through Year 5 (current LTE study))
研究者
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