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

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат TAK-360
  TAK-360 tablet
• Препарат Placebo
  TAK-360 matching placebo tablet

Первичные конечные точки

• Parts A, B and C: Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 28 weeks]

Вторичные конечные точки (3)

• Parts A and B: Change from Baseline in Mean Sleep Latency From the Maintenance of Wakefulness Test (MWT) at Week 6 [Срок оценки: Baseline, Week 6]
• Parts A and B: Change from Baseline in Epworth Sleepiness Scale (ESS) Total Score at Week 6 [Срок оценки: Baseline, Week 6]
• Parts A and B: Weekly Cataplexy Rate (WCR) at Week 6 [Срок оценки: Week 6]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Япония · 5 центров

• Takeda Site 17 — Fukuoka
• Takeda Site 1 — Kumamoto
• Takeda Site 18 — Isahaya-shi
• Takeda Site 15 — Yodogawa-ku, Osaka-shi
• Takeda Site 16 — Shinjuku-ku

США · 3 центра

• Takeda Site 12 — Redwood City
• Takeda Site 14 — Miami
• Takeda Site 13 — Cincinnati

Китай · 3 центра

• Takeda Site 4 — Пекин
• Takeda Site 3 — Гуанчжоу
• Takeda Site 5 — Чжэнчжоу

Франция · 2 центра

• Takeda Site 6 — Herault
• Takeda Site 7 — Paris

Италия · 2 центра

• Takeda Site 8 — Bologna
• Takeda Site 9 — Verona

Испания · 2 центра

• Takeda Site 11 — Barcelona
• Takeda Site 10 — Madrid

Австралия · 1 центр

• Takeda Site 2 — Macquarie Park

Идентификаторы

NCT: NCT07633301 · TAK-360-2004 · 2025-522587-33-00 · jRCT2031260186

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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