A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Официальное название

A Dose-Finding, Adaptive, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Idiopathic Hypersomnia (IH)

Обзор

Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that. Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.

Вмешательства

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

Первичные конечные точки

• Number of Participants With at Least One Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to Week 8]

Вторичные конечные точки (2)

• Change from Baseline at Week 4 in Epworth Sleepiness Scale (ESS) Total Score [Срок оценки: Baseline, Week 4]
• Change from Baseline at Week 4 in Idiopathic Hypersomnia Severity Scale (IHSS) Total Score [Срок оценки: Baseline, Week 4]

Критерии участия

Критерии включения

• The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\].
• The participant has a documented, current diagnosis of IH.

Критерии исключения

• The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) \[other than IH\].
• The participant has medically significant thyroid disease.
• The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.)
• The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening).
• The participant has a clinically significant history of head injury or head trauma.
• The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood).
• The participant has a history of cerebral ischemia, transient ischemic attack (less than \[<\]5 years from screening), intracranial aneurysm, or arteriovenous malformation.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 13 центров

• Takeda Site 11 — Redwood City
• Takeda Site 10 — Santa Ana
• Takeda Site 27 — Colorado Springs
• Takeda Site 19 — Brandon
• Takeda Site 14 — Winter Park
• Takeda Site 29 — St Louis
• Takeda Site 16 — Denver
• Takeda Site 15 — Huntersville
• … и ещё 5 центров

Япония · 6 центров

• Takeda Site 25 — Fukuoka-Shi Hakata-Ku
• Takeda Site 23 — Kurume-shi
• Takeda Site 22 — Kohoku-ku, Yokohama-Shi
• Takeda Site 20 — Kumamoto
• Takeda Site 21 — Yodogawa-ku, Osaka-shi
• Takeda Site 24 — Bunkyo-ku

Италия · 4 центра

• Takeda Site 6 — Pozzilli
• Takeda Site 7 — Rome
• Takeda Site 26 — Verona
• Takeda Site 5 — Bologna

Франция · 3 центра

• Takeda Site 1 — Montpellier
• Takeda Site 3 — Nantes
• Takeda Site 2 — Paris

Испания · 2 центра

• Takeda Site 9 — Vitoria-Gasteiz
• Takeda Site 8 — Madrid

Гонконг · 1 центр

• Takeda Site 4 — Shatin

Идентификаторы

NCT: NCT06812078 · TAK-360-2002 · 2024-517712-29-00 · jRCT2031240669

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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