A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-861 for the Treatment of Narcolepsy Without Cataplexy (Narcolepsy Type 2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 56
- 主要终点
- Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
研究概览
简要总结
The main aim is to evaluate the effect of TAK-861 on symptoms of narcolepsy, including excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).
The study will enroll approximately 60 participants and they will be randomly assigned to 3 groups (20 per group) to take one of two different doses of TAK-861 or a placebo. All the participants will receive the treatment for 8 weeks. Participants will be asked to complete some questionnaires during the study. This trial will be conducted in North America, Europe, and Asia Pacific.
详细描述
The drug being tested in this study is called TAK-861. TAK-861 is being tested to treat people who have narcolepsy without cataplexy [Narcolepsy Type 2 (NT2)]. This study will evaluate the efficacy, safety, and tolerability of 2 oral doses of TAK-861.
The study will enroll approximately 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- TAK-861 Dose 1
- TAK-861 Dose 2
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
This is a multi-center trial to be conducted worldwide. The overall time to participate in this study is approximately 18 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is aged 18 to 70 years, inclusive, at the time of signing the informed consent form (ICF).
- •Note: In Japan, participants aged 16 to 70 years, inclusive, may be included.
- •The participant has an International Classification of Sleep Disorders, 3rd edition (ICSD-3) diagnosis of NT2 by preceding polysomnography (PSG)/ multiple sleep latency test (MSLT), performed within the past 5 years.
- •Note: If there is a potential participant with NT2 for whom a diagnostic nocturnal polysomnography (nPSG)/MSLT was performed more than 5 years ago or is not available, the site may repeat the diagnostic PSG/MSLT.
排除标准
- •The participant has a current medical disorder, other than narcolepsy without cataplexy, associated with EDS.
- •The participant has history of epilepsy, seizure, or convulsion, or has a family history of inherited disorders associated with seizure (except for a single febrile seizure in childhood).
- •The participant has one or more of the following psychiatric disorders:
- •Any current unstable psychiatric disorder.
- •Current or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
- •Current diagnosis or history of substance use disorder as defined in the DSM-
- •Note: If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the study after consultation with the sponsor or designee. (Participant must also have negative urine drug screen at the screening and Day -2 visit.)
- •Current active major depressive episode (MDE) or who have had an active MDE in the past 6 months.
- •The participant has a history of cerebral ischemia, transient ischemic attack (<5 years ago), intracranial aneurysm, or arteriovenous malformation.
- •The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
研究组 & 干预措施
Placebo
Participants received placebo tablets matching TAK-861, orally, twice daily (BID), from Days 1 to 56.
干预措施: Placebo (Drug)
TAK-861 2 milligrams (mg) BID
Participants received TAK-861 2 mg, orally, BID, from Days 1 to 56.
干预措施: TAK-861 2 mg (Drug)
TAK-861 2 mg and 5 mg
Participants received TAK-861 2 mg followed by the 5 mg dose, orally, from Days 1 to 56.
干预措施: TAK-861 2 mg and 5 mg (Drug)
结局指标
主要结局
Change From Baseline in the Average Sleep Latency as Determined From the MWT at Week 8
时间窗: Baseline, Week 8
The MWT is a validated, objective measure that evaluates a participant's ability to remain awake under soporific conditions for a defined period. During each MWT session (1 session = 40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on EEG. If no sleep was observed according to these rules, then the latency was defined as 40 minutes. The linear mixed effects model for repeated measures (MMRM) was used for analysis.
次要结局
- Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 8(Baseline, Week 8)
- Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)(From first dose of the study drug up to end of the study (up to 3 months))