A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
17 de septiembre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
500
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Study Director
- Número de teléfono: +1-877-825-3327
- Correo electrónico: medinfoUS@takeda.com
Ubicaciones de estudio
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New South Wales
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Macquarie Park, New South Wales, Australia, 2113
- Reclutamiento
- Takeda Site 15
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Daegu Gwang'yeogsi
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Daegu, Daegu Gwang'yeogsi, Corea del Sur, 42601
- Reclutamiento
- Takeda Site 17
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California
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Chula Vista, California, Estados Unidos, 91910
- Reclutamiento
- Takeda Site 23
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80918
- Reclutamiento
- Takeda Site 14
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Florida
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Brandon, Florida, Estados Unidos, 33511
- Reclutamiento
- Takeda Site 11
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Miami, Florida, Estados Unidos, 33176
- Reclutamiento
- Takeda Site 7
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Winter Park, Florida, Estados Unidos, 32789
- Reclutamiento
- Takeda Site 18
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Georgia
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Atlanta, Georgia, Estados Unidos, 30328
- Reclutamiento
- Takeda Site 6
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Michigan
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Southfield, Michigan, Estados Unidos, 48075
- Reclutamiento
- Takeda Site 21
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Missouri
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St Louis, Missouri, Estados Unidos, 63123
- Reclutamiento
- Takeda Site 9
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New Jersey
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Middletown, New Jersey, Estados Unidos, 07748
- Reclutamiento
- Takeda Site 19
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North Carolina
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Denver, North Carolina, Estados Unidos, 28037
- Reclutamiento
- Takeda Site 24
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Huntersville, North Carolina, Estados Unidos, 28078
- Reclutamiento
- Takeda Site 10
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Reclutamiento
- Takeda Site 22
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45245
- Reclutamiento
- Takeda Site 2
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Cincinnati, Ohio, Estados Unidos, 45245
- Reclutamiento
- Takeda Site 4
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South Carolina
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Columbia, South Carolina, Estados Unidos, 29021
- Reclutamiento
- Takeda Site 8
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Texas
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Austin, Texas, Estados Unidos, 78731
- Reclutamiento
- Takeda Site 20
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San Antonio, Texas, Estados Unidos, 78229
- Reclutamiento
- Takeda Site 3
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Kumamoto
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Kumamoto, Kumamoto, Japón, 162-0851
- Reclutamiento
- Takeda Site 13
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Tokyo
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Shinjuku-ku, Tokyo, Japón, 162-0851
- Reclutamiento
- Takeda Site 1
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Beijing Municipality
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Xicheng, Beijing Municipality, Porcelana, 100053
- Reclutamiento
- Takeda Site 12
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510515
- Reclutamiento
- Takeda Site 5
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Henan
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Zhenzhou, Henan, Porcelana, 450003
- Reclutamiento
- Takeda Site 16
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Key Inclusion Criteria:
- Participant is willing and able to understand and fully comply with trial procedures and requirements.
- Participant has a confirmed diagnosis of either NT1, NT2, or IH, and has completed the treatment period of a parent TAK-360 trial.
- 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:
- Participant has a positive pregnancy test or is lactating/breastfeeding.
- Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- The participant has developed a new medical disorder associated with excessive daytime sleep (EDS).
- Participant has developed (within the last 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.
- Participant has developed a new history of seizures.
- Participant has experienced clinically significant head injury, per investigator opinion.
- Participant has developed a history of cerebral ischemia, transient ischemic attack (less than [<] 5 years ago), or cerebral haemorrhage.
- Participant has developed a history of myocardial infarction, clinically significant coronary artery disease, clinically significant angina, clinically significant cardiac rhythm abnormality, or heart failure.
- 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.
- Participant has developed a history of cancer in the past 5 years.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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TAK-360 tablets
TAK-360-matching placebo tablets
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With at Least 1 Treatment-Emergent Adverse Event (TEAE)
Periodo de tiempo: Up to approximately 5 years
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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.
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Up to approximately 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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All Participants: Change From Baseline in Epworth Sleepiness Scale (ESS) Total Score
Periodo de tiempo: Baseline through Year 5
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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 normal range.
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Baseline through Year 5
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All Participants: Change from Baseline in Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT)
Periodo de tiempo: Baseline through Month 6
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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.
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Baseline through Month 6
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Change from Baseline in Weekly Cataplexy Rate (WCR) Using the Participant-Reported Cataplexy eDiary
Periodo de tiempo: Baseline, Month 3 through Month 24
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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.
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Baseline, Month 3 through Month 24
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IH Participants: Change From Baseline in IH Severity Scale (IHSS) Total Score
Periodo de tiempo: Baseline through Year 5
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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.
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Baseline through Year 5
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NT1 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-CT)
Periodo de tiempo: Baseline through Year 5
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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.
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Baseline through Year 5
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NT2 Participants: Change From Baseline on the Narcolepsy Severity Scale for Clinical Trials (NSS-2-CT)
Periodo de tiempo: Baseline, Month 1 through Year 5
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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.
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Baseline, Month 1 through Year 5
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Takeda Contact, Takeda
Publicaciones y enlaces útiles
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Enlaces Útiles
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de junio de 2026
Finalización primaria (Estimado)
15 de junio de 2031
Finalización del estudio (Estimado)
15 de junio de 2031
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de junio de 2026
Publicado por primera vez (Actual)
15 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TAK-360-2003
- 2025 (Subvención/contrato del NIH de EE. UU.: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- jRCT2031260198 (Otro identificador: jRCT)
- 2025-522833-68-01 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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