A Study of TAK-360 in Adults With Narcolepsy Type 1 (Narcolepsy With Cataplexy)
26 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
92
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Takeda Contact
- Numéro de téléphone: +1-877-825-3327
- E-mail: medinfoUS@takeda.com
Lieux d'étude
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New South Wales
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Macquarie Park, New South Wales, Australie, 2113
- Pas encore de recrutement
- Takeda Site 2
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100053
- Recrutement
- Takeda Site 4
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Guangdong
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Guangzhou, Guangdong, Chine, 510515
- Recrutement
- Takeda Site 3
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Henan
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Zhengzhou, Henan, Chine, 450003
- Recrutement
- Takeda Site 5
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Barcelona, Espagne, 8036
- Pas encore de recrutement
- Takeda Site 11
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Madrid, Espagne, 28043
- Pas encore de recrutement
- Takeda Site 10
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Paris, France, 75013
- Pas encore de recrutement
- Takeda Site 7
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Montpelier
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Herault, Montpelier, France, 34000
- Pas encore de recrutement
- Takeda Site 6
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italie, 40139
- Pas encore de recrutement
- Takeda Site 8
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Veneto
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Verona, Veneto, Italie, 37134
- Pas encore de recrutement
- Takeda Site 9
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Fukuoka
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Fukuoka, Fukuoka, Japon, 812-0025
- Recrutement
- Takeda Site 17
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Kumamoto
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Kumamoto, Kumamoto, Japon, 862-0954
- Recrutement
- Takeda Site 1
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Nagasaki
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Isahaya-shi, Nagasaki, Japon, 854-0081
- Recrutement
- Takeda Site 18
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Osaka
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Yodogawa-ku, Osaka-shi, Osaka, Japon, 532-0003
- Pas encore de recrutement
- Takeda Site 15
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Tokyo
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Shinjuku-ku, Tokyo, Japon, 162-0851
- Recrutement
- Takeda Site 16
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California
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Redwood City, California, États-Unis, 94063
- Pas encore de recrutement
- Takeda Site 12
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Florida
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Miami, Florida, États-Unis, 33176
- Recrutement
- Takeda Site 14
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Ohio
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Cincinnati, Ohio, États-Unis, 45245
- Recrutement
- Takeda Site 13
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Part A: TAK-360
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Comparateur placebo: 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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Expérimental: Part B: TAK-360
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Comparateur placebo: 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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Expérimental: Part C
Participants will receive TAK-360 tablets, orally.
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TAK-360 tablet
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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
Délai: 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
Délai: Week 6
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Week 6
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Study Director, Takeda
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
4 juin 2026
Achèvement primaire (Estimé)
28 novembre 2027
Achèvement de l'étude (Estimé)
28 novembre 2027
Dates d'inscription aux études
Première soumission
2 juin 2026
Première soumission répondant aux critères de contrôle qualité
2 juin 2026
Première publication (Réel)
8 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TAK-360-2004
- 2025-522587-33-00 (Ctis)
- jRCT2031260186 (Autre identifiant: jRCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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