A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
26 juni 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
92
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Takeda Contact
- Telefonnummer: +1-877-825-3327
- E-post: medinfoUS@takeda.com
Studieorter
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New South Wales
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Macquarie Park, New South Wales, Australien, 2113
- Har inte rekryterat ännu
- Takeda Site 2
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Paris, Frankrike, 75013
- Har inte rekryterat ännu
- Takeda Site 7
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Montpelier
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Herault, Montpelier, Frankrike, 34000
- Har inte rekryterat ännu
- Takeda Site 6
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California
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Redwood City, California, Förenta staterna, 94063
- Har inte rekryterat ännu
- Takeda Site 12
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Florida
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Miami, Florida, Förenta staterna, 33176
- Rekrytering
- Takeda Site 14
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45245
- Rekrytering
- Takeda Site 13
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italien, 40139
- Har inte rekryterat ännu
- Takeda Site 8
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Veneto
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Verona, Veneto, Italien, 37134
- Har inte rekryterat ännu
- Takeda Site 9
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Fukuoka
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Fukuoka, Fukuoka, Japan, 812-0025
- Rekrytering
- Takeda Site 17
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Kumamoto
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Kumamoto, Kumamoto, Japan, 862-0954
- Rekrytering
- Takeda Site 1
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Nagasaki
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Isahaya-shi, Nagasaki, Japan, 854-0081
- Rekrytering
- Takeda Site 18
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Osaka
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Yodogawa-ku, Osaka-shi, Osaka, Japan, 532-0003
- Har inte rekryterat ännu
- Takeda Site 15
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Tokyo
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Shinjuku-ku, Tokyo, Japan, 162-0851
- Rekrytering
- Takeda Site 16
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100053
- Rekrytering
- Takeda Site 4
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Rekrytering
- Takeda Site 3
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Henan
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Zhengzhou, Henan, Kina, 450003
- Rekrytering
- Takeda Site 5
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Barcelona, Spanien, 8036
- Har inte rekryterat ännu
- Takeda Site 11
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Madrid, Spanien, 28043
- Har inte rekryterat ännu
- Takeda Site 10
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Key Inclusion Criteria:
- The participant has a body mass index within the range 18 to 40 kilograms per meter square (kg/m^2) (inclusive).
- The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or ICSD-3 Text Revision diagnosis of NT1.
Key Exclusion Criteria:
- The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with excessive daytime sleepiness.
- 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.
- The participant has a clinically significant history of head injury or head trauma.
- The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).
- The participant has a history of cerebral ischemia, transient ischemic attack (<5 years from screening), intracranial aneurysm, or arteriovenous malformation.
- 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).
- 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.
- 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.
- The participant has a known hypersensitivity to any component of the formulation of TAK-360 or related compounds.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Part A: TAK-360
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Placebo-jämförare: Part A: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
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TAK-360 matching placebo tablet
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Experimentell: Part B: TAK-360
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Placebo-jämförare: Part B: Placebo
Participants will receive TAK-360 matching placebo tablets, orally.
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TAK-360 matching placebo tablet
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Experimentell: Part C
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Tidsram: Up to approximately 28 weeks
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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.
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Up to approximately 28 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6
Tidsram: Baseline, Week 6
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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.
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Baseline, Week 6
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Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6
Tidsram: Baseline, Week 6
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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.
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Baseline, Week 6
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Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6
Tidsram: Week 6
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Week 6
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Study Director, Takeda
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 juni 2026
Primärt slutförande (Beräknad)
28 november 2027
Avslutad studie (Beräknad)
28 november 2027
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TAK-360-2004
- 2025-522587-33-00 (Ctis)
- jRCT2031260186 (Annan identifierare: jRCT)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .