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

26. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

92

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113
        • Har ikke rekruttert ennå
        • Takeda Site 2
  • Forente stater
    • California
      • Redwood City, California, Forente stater, 94063
        • Har ikke rekruttert ennå
        • Takeda Site 12
    • Florida
      • Miami, Florida, Forente stater, 33176
        • Rekruttering
        • Takeda Site 14
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45245
        • Rekruttering
        • Takeda Site 13
  • Frankrike
      • Paris, Frankrike, 75013
        • Har ikke rekruttert ennå
        • Takeda Site 7
    • Montpelier
      • Herault, Montpelier, Frankrike, 34000
        • Har ikke rekruttert ennå
        • Takeda Site 6
  • Italia
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italia, 40139
        • Har ikke rekruttert ennå
        • Takeda Site 8
    • Veneto
      • Verona, Veneto, Italia, 37134
        • Har ikke rekruttert ennå
        • Takeda Site 9
  • Japan
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-0025
        • Rekruttering
        • Takeda Site 17
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 862-0954
        • Rekruttering
        • Takeda Site 1
    • Nagasaki
      • Isahaya-shi, Nagasaki, Japan, 854-0081
        • Rekruttering
        • Takeda Site 18
    • Osaka
      • Yodogawa-ku, Osaka-shi, Osaka, Japan, 532-0003
        • Har ikke rekruttert ennå
        • Takeda Site 15
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan, 162-0851
        • Rekruttering
        • Takeda Site 16
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100053
        • Rekruttering
        • Takeda Site 4
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Rekruttering
        • Takeda Site 3
    • Henan
      • Zhengzhou, Henan, Kina, 450003
        • Rekruttering
        • Takeda Site 5
  • Spania
      • Barcelona, Spania, 8036
        • Har ikke rekruttert ennå
        • Takeda Site 11
      • Madrid, Spania, 28043
        • Har ikke rekruttert ennå
        • Takeda Site 10

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Part A: TAK-360
Participants will receive TAK-360 tablets, orally.
Legemiddel: TAK-360
TAK-360 tablet
Placebo komparator: Part A: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
Legemiddel: Placebo
TAK-360 matching placebo tablet
Eksperimentell: Part B: TAK-360
Participants will receive TAK-360 tablets, orally.
Legemiddel: TAK-360
TAK-360 tablet
Placebo komparator: Part B: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
Legemiddel: Placebo
TAK-360 matching placebo tablet
Eksperimentell: Part C
Participants will receive TAK-360 tablets, orally.
Legemiddel: TAK-360
TAK-360 tablet

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 6
Week 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Takeda

Etterforskere

  • Studieleder: Study Director, Takeda

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. juni 2026

Primær fullføring (Antatt)

28. november 2027

Studiet fullført (Antatt)

28. november 2027

Datoer for studieregistrering

Først innsendt

2. juni 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TAK-360-2004
  • 2025-522587-33-00 (Ctis)
  • jRCT2031260186 (Annen identifikator: jRCT)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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