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A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia

2026年9月17日 更新者：Takeda

A Long-term Extension Trial to Evaluate the Safety and Tolerability of TAK-360 in Participants With Selected Central Hypersomnia Conditions

Central hypersomnia conditions are a group of sleeping disorders where the brain has trouble keeping a person awake during the day (called excessive daytime sleepiness or EDS). These conditions usually include narcolepsy (type 1 and 2) and idiopathic hypersomnia (IH). Narcolepsy type 1 (NT1) includes sudden muscle weakness while you stay awake, called cataplexy, often triggered by strong emotions. Narcolepsy type 2 (NT2) does not include cataplexy. People with narcolepsy typically feel refreshed by short naps. People with IH feel extremely sleepy during the day, and do not feel refreshed by sleep. Waking up from sleep is difficult. This is common in the morning and also when waking up from long naps.

The study wants to learn about TAK-360 when taken over a long time period; this is called a long-term extension or LTE study. The main aim of this LTE study is to find out how well participants with NT1, NT2, and IH tolerate TAK-360 over a longer period (long-term tolerability) and to learn how safe TAK-360 is when given over a longer period of time (long-term safety).

Participants who completed one of the TAK-360 parent studies can join this study if they meet the study rules. Parent studies include TAK-360-2001(NCT06952699), TAK-360-2002 (NCT06812078), or other TAK-360 studies that evaluate the TAK-360 medicine. All participants will receive TAK-360 in this study. They will either receive the same dose as they did in the parent study, or the closest dose available in this LTE study. Participants who received placebo (the placebo looks just like TAK-360 but does not have any medicine in it) in their parent study will receive one of the TAK-360 doses available in this study. Placebo will only be used to not reveal the dose of TAK-360 from parent studies to investigator, participants, and sponsor. Sponsor, investigators and participants will not know which TAK-360 dose was used in the LTE study as long as the parent study is ongoing.

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)

500

阶段

  • 阶段2
  • 第三阶段

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
      • Xicheng、Beijing Municipality、中国、100053
        • 招聘中
        • Takeda Site 12
    • Guangdong
      • Guangzhou、Guangdong、中国、510515
        • 招聘中
        • Takeda Site 5
    • Henan
      • Zhenzhou、Henan、中国、450003
        • 招聘中
        • Takeda Site 16
  • 日本
    • Kumamoto
      • Kumamoto、Kumamoto、日本、162-0851
        • 招聘中
        • Takeda Site 13
    • Tokyo
      • Shinjuku-ku、Tokyo、日本、162-0851
        • 招聘中
        • Takeda Site 1
  • 澳大利亚
    • New South Wales
      • Macquarie Park、New South Wales、澳大利亚、2113
        • 招聘中
        • Takeda Site 15
  • 美国
    • California
      • Chula Vista、California、美国、91910
        • 招聘中
        • Takeda Site 23
    • Colorado
      • Colorado Springs、Colorado、美国、80918
        • 招聘中
        • Takeda Site 14
    • Florida
      • Brandon、Florida、美国、33511
        • 招聘中
        • Takeda Site 11
      • Miami、Florida、美国、33176
        • 招聘中
        • Takeda Site 7
      • Winter Park、Florida、美国、32789
        • 招聘中
        • Takeda Site 18
    • Georgia
      • Atlanta、Georgia、美国、30328
        • 招聘中
        • Takeda Site 6
    • Michigan
      • Southfield、Michigan、美国、48075
        • 招聘中
        • Takeda Site 21
    • Missouri
      • St Louis、Missouri、美国、63123
        • 招聘中
        • Takeda Site 9
    • New Jersey
      • Middletown、New Jersey、美国、07748
        • 招聘中
        • Takeda Site 19
    • North Carolina
      • Denver、North Carolina、美国、28037
        • 招聘中
        • Takeda Site 24
      • Huntersville、North Carolina、美国、28078
        • 招聘中
        • Takeda Site 10
      • Winston-Salem、North Carolina、美国、27103
        • 招聘中
        • Takeda Site 22
    • Ohio
      • Cincinnati、Ohio、美国、45245
        • 招聘中
        • Takeda Site 2
      • Cincinnati、Ohio、美国、45245
        • 招聘中
        • Takeda Site 4
    • South Carolina
      • Columbia、South Carolina、美国、29021
        • 招聘中
        • Takeda Site 8
    • Texas
      • Austin、Texas、美国、78731
        • 招聘中
        • Takeda Site 20
      • San Antonio、Texas、美国、78229
        • 招聘中
        • Takeda Site 3
  • 韩国
    • Daegu Gwang'yeogsi
      • Daegu、Daegu Gwang'yeogsi、韩国、42601
        • 招聘中
        • Takeda Site 17

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. Participant is willing and able to understand and fully comply with trial procedures and requirements.
  2. Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.
  3. Participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) and any required privacy authorization before the initiation of any trial procedures.

Key Exclusion Criteria:

  1. Participant has a positive pregnancy test or is lactating/breastfeeding.
  2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
  3. The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
  4. Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
  5. Participant has developed a new history of seizures.
  6. Participant has experienced clinically significant head injury, per investigator opinion.
  7. Participant has developed a history of cerebral ischemia, transient ischemic attack (less than [<] 5 years ago), or cerebral haemorrhage.
  8. Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
  9. The participant has been diagnosed with medically significant thyroid disease, known functional hepatic impairment, or other severe chronic medical condition other than the central hypersomnolence disorder.
  10. Participant has developed a history of cancer in the past 5 years.

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：TAK-360 Long Term Extension (LTE) Phase
Participants will receive one of the available TAK-360 doses for up to approximately 5 years in this trial. Participants will enter the LTE on the dose they were in the parent trial or for participants with discontinued dosing regimen in the parent trial to the next closest available dose/dosing regimen for their indication in this trial. Participants rolling over to this trial from a placebo arm in the parent trial, will receive one of the available TAK-360 doses. Placebo will be only administered as needed to maintain dose blinding between TAK-360 doses and regimens.
药品：TAK-360
TAK-360 tablets
药品：Placebo
TAK-360-matching placebo tablets

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
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
大体时间：Up to approximately 5 years
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.
Up to approximately 5 years

次要结果测量

结果测量
措施说明
大体时间
All Participants: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
大体时间：Baseline through Year 5
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 normal range.
Baseline through Year 5
All Participants: Change from Baseline in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
大体时间：Baseline through Month 6
The MWT evaluates a participant's ability to remain awake under soporific conditions for a defined period. Because there is no biological measure of wakefulness, wakefulness is measured indirectly by the inability or delayed tendency to fall asleep. This tendency to fall asleep is measured via electroencephalography-derived sleep latency in the MWT. One MWT, that includes four 40-minute wake trials, will be done. Sleep latency in each wake trial will be recorded. Participants will be required to stay awake in between the 4 MWT wake trials.
Baseline through Month 6
Change from Baseline in Weekly Cataplexy Rate (WCR) Using the Participant-Reported Cataplexy eDiary
大体时间：Baseline, Month 3 through Month 24
Participants will complete a patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy attacks in the diary. The total number of events averaged for a week will be reported.
Baseline, Month 3 through Month 24
IH Participants: Change From Baseline in IH Severity Scale (IHSS) Total Score
大体时间：Baseline through Year 5
The IHSS is a 14-item self-assessment questionnaire, to measure the severity, frequency and functional impact of the 3 key IH symptoms (during a recall period of "past 7 days"). The IHSS includes 2 items (1 and 2) on nighttime sleep duration and quality, 3 items (3, 4, and 5) on sleep inertia and sleep drunkenness after nighttime sleep and 1 (8) after daytime nap, and 3 items (6, 7, and 9) on diurnal symptoms (nap occurrence, daytime sleepiness). Items 10 to 14 assess daytime functioning alterations due to hypersomnolence. Six items (1,2,3,5,7,8) are scored with 4 ranged response options, with score from 0 to 3, and 8 items (4,6,9,10,11,12,13,14) with 5 ranged response options, with score from 0 to 4, with 1 additional response option for item 14. The total IHSS score is the sum of all item scores (range: 0 to 50); higher scores indicate more severe symptoms.
Baseline through Year 5
NT1 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT)
大体时间：Baseline through Year 5
The NSS-CT is a 15-item self-administered questionnaire that assesses the severity and consequences of the 5 major narcolepsy symptoms such as daytime sleepiness, cataplexy, hallucinations, sleep paralysis, and disrupted nighttime sleep (DNS) with a total score range of 0 to 57 (sum of 8 items that assess symptoms severity [2 with 4 response options, 1 response with 6 options, and 5 items capturing event count], and 7 items that describe the symptom effect on daily life with 4 response options). The presence of narcolepsy symptoms is defined by EDS (score greater than or equal to [≥] 1 on at least one of items 1, 2, 3, 4, 5, 6, or 7), cataplexy (score ≥1 on at least one of items 8, 9, or 10), hallucinations (score ≥1 on at least one of items 11 and 12), sleep paralysis (score ≥1 on at least one of the items 13 and 14), and disrupted nighttime sleep by a score ≥1 on item 15. Higher scores indicate greater symptom severity or degree of impact.
Baseline through Year 5
NT2 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-2-CT)
大体时间：Baseline, Month 1 through Year 5
The NSS-2-CT is a 12-item self-administered questionnaire that assesses the severity and consequences of major narcolepsy symptoms such as daytime sleepiness, hallucinations, sleep paralysis, and disrupted nighttime sleep, with higher scores indicating more severe narcolepsy symptoms and impacts. The total score ranges from 0-44(sum of 6 items that assess event symptom severity [including 2 items with 4 response options, 1 item with 6 response options, and 3 items capturing event count], and 6 items that describe symptom effect on daily life, with 4 response options), and differs from the NSS-CT in its omission of cataplexy-related items. The presence of narcolepsy symptoms is defined by EDS (score ≥1 on at least one of items 1, 2, 3, 4, 5, 6, or 7), hallucinations (score ≥1 on at least one of items 8 and 9), sleep paralysis (score ≥1 on at least one of the items 10 and 11), and disrupted nighttime sleep by a score ≥1 on item 12.
Baseline, Month 1 through Year 5

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：Takeda Contact、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11日

初级完成 (估计的)

2031年6月15日

研究完成 (估计的)

2031年6月15日

研究注册日期

首次提交

2026年6月9日

首先提交符合 QC 标准的

2026年6月9日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9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-360-2003
  • 2025 (美国 NIH 拨款/合同：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • jRCT2031260198 (其他标识符：jRCT)
  • 2025-522833-68-01 (克蒂斯)

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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