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

2026년 9월 17일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

500

단계

  • 2 단계
  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: TAK-360
TAK-360 tablets
의약품: Placebo
TAK-360-matching placebo tablets

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
All Participants: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Takeda

수사관

  • 연구 책임자: Takeda Contact, Takeda

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 11일

기본 완료 (추정된)

2031년 6월 15일

연구 완료 (추정된)

2031년 6월 15일

연구 등록 날짜

최초 제출

2026년 6월 9일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 15일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TAK-360-2003
  • 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • jRCT2031260198 (기타 식별자: jRCT)
  • 2025-522833-68-01 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다