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A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)

2026年6月26日 更新者：Takeda

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)

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

92

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100053
        • 招聘中
        • Takeda Site 4
    • Guangdong
      • Guangzhou、Guangdong、中国、510515
        • 招聘中
        • Takeda Site 3
    • Henan
      • Zhengzhou、Henan、中国、450003
        • 招聘中
        • Takeda Site 5
  • 意大利
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40139
        • 尚未招聘
        • Takeda Site 8
    • Veneto
      • Verona、Veneto、意大利、37134
        • 尚未招聘
        • Takeda Site 9
  • 日本
    • Fukuoka
      • Fukuoka、Fukuoka、日本、812-0025
        • 招聘中
        • Takeda Site 17
    • Kumamoto
      • Kumamoto、Kumamoto、日本、862-0954
        • 招聘中
        • Takeda Site 1
    • Nagasaki
      • Isahaya-shi、Nagasaki、日本、854-0081
        • 招聘中
        • Takeda Site 18
    • Osaka
      • Yodogawa-ku, Osaka-shi、Osaka、日本、532-0003
        • 尚未招聘
        • Takeda Site 15
    • Tokyo
      • Shinjuku-ku、Tokyo、日本、162-0851
        • 招聘中
        • Takeda Site 16
  • 法国
      • Paris、法国、75013
        • 尚未招聘
        • Takeda Site 7
    • Montpelier
      • Herault、Montpelier、法国、34000
        • 尚未招聘
        • Takeda Site 6
  • 澳大利亚
    • New South Wales
      • Macquarie Park、New South Wales、澳大利亚、2113
        • 尚未招聘
        • Takeda Site 2
  • 美国
    • California
      • Redwood City、California、美国、94063
        • 尚未招聘
        • Takeda Site 12
    • Florida
      • Miami、Florida、美国、33176
        • 招聘中
        • Takeda Site 14
    • Ohio
      • Cincinnati、Ohio、美国、45245
        • 招聘中
        • Takeda Site 13
  • 西班牙
      • Barcelona、西班牙、8036
        • 尚未招聘
        • Takeda Site 11
      • Madrid、西班牙、28043
        • 尚未招聘
        • Takeda Site 10

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Key Inclusion Criteria:

  1. The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m^2) (inclusive).
  2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.

Key Exclusion Criteria:

  1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
  2. 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.
  3. The participant has a clinically significant history of head injury or head trauma.
  4. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
  5. The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
  6. 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).
  7. 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.
  8. 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-360-2004.
  9. The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Part A: TAK-360
Participants will receive TAK-360 tablets, orally.
药品：TAK-360
TAK-360 tablet
安慰剂比较：Part A: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
药品：Placebo
TAK-360 matching placebo tablet
实验性的：Part B: TAK-360
Participants will receive TAK-360 tablets, orally.
药品：TAK-360
TAK-360 tablet
安慰剂比较：Part B: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
药品：Placebo
TAK-360 matching placebo tablet
实验性的：Part C
Participants will receive TAK-360 tablets, orally.
药品：TAK-360
TAK-360 tablet

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
大体时间：Up to approximately 28 weeks
An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. 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.
Up to approximately 28 weeks

次要结果测量

结果测量
措施说明
大体时间
Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
大体时间：Baseline, Week 6
The MWT evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep.
Baseline, Week 6
Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
大体时间：Baseline, Week 6
The ESS provides individuals with 8 different situations of daily life and asks them how likely they are to fall asleep in those situations (scored 0 to 3) and to try to imagine their likelihood of dozing even if they have not actually been in the identical situation; the scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the reference range.
Baseline, Week 6
Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6
大体时间：Week 6
Week 6

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Takeda

调查人员

  • 研究主任：Study Director、Takeda

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月4日

初级完成 (估计的)

2027年11月28日

研究完成 (估计的)

2027年11月28日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月29日

上次提交的符合 QC 标准的更新

2026年6月26日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TAK-360-2004
  • 2025-522587-33-00 (克蒂斯)
  • jRCT2031260186 (其他标识符：jRCT)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD 共享访问标准

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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