A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 55
- 主要终点
- Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake.
The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that.
Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
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
- •The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m^2) [inclusive].
- •The participant has a documented, current diagnosis of IH.
排除标准
- •The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) [other than IH].
- •The participant has medically significant thyroid disease.
- •The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ [such as basal cell carcinoma] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
- •The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
- •The participant has a clinically significant history of head injury or head trauma.
- •The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
- •The participant has a history of cerebral ischemia, transient ischemic attack (less than [<]5 years from screening), intracranial aneurysm, or arteriovenous malformation.
研究组 & 干预措施
Placebo
Participants will receive TAK-360 matching placebo tablets, orally, for 4 weeks.
干预措施: Placebo (Other)
TAK-360
Participants will receive TAK-360 tablets, orally, for 4 weeks.
干预措施: TAK-360 (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to Week 8
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.
次要结局
- Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score(Baseline, Week 4)
- Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score(Baseline, Week 4)