A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 18
研究概览
简要总结
Narcolepsy is a sleep disorder that disrupts a person's regular sleep-wake cycle. It causes extreme sleepiness during the day (called excessive daytime sleepiness [EDS]), where a person may fall asleep without warning. Narcolepsy Type 1 (NT1) is a form of the condition in which people also have sudden, unexpected muscle weakness while staying conscious (called cataplexy).
The main aim of this study is to learn how safe TAK-360 is and how well adults with NT1 tolerate it. Adults who can participate in the study will have to stop taking their existing medicines for NT1 before study treatment starts. Participants may be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo during the treatment period. The placebo looks just like TAK-360 but does not have any medicine in it. After the treatment period, participants can be monitored for another 2 weeks. Participants can restart their usual NT1 treatment after study treatment ends.
The participants will have to visit the clinic multiple times during this study.
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
- Triple (Participant, 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 has a body mass index within the range 18 to 40 kilograms per meter square (kg/m^2) (inclusive).
- •The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT
排除标准
- •The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
- •The participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure.
- •The participant has a clinically significant history of head injury or head trauma.
- •The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
- •The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
- •The participant has a history of cancer in the past 5 years (does not apply to participants with carcinoma in situ that has been resolved without further treatment or basal cell carcinoma; these participants may be included after approval by the medical monitor).
- •The participant has a positive test result for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody/antigen at screening.
- •The participant plans to participate in any other interventional trial while participating in TAK-360-2004 or has previously participated in another part in TAK-360-
- •The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.
研究组 & 干预措施
Part A: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
干预措施: Placebo (Drug)
Part B: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
干预措施: Placebo (Drug)
Part C
Participants will receive TAK-360 tablets, orally.
干预措施: TAK-360 (Drug)
Part B: TAK-360
Participants will receive TAK-360 tablets, orally.
干预措施: TAK-360 (Drug)
Part A: TAK-360
Participants will receive TAK-360 tablets, orally.
干预措施: TAK-360 (Drug)