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Идёт набор NCT06952699

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Фаза II С лечением Narcolepsy Type 2

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: TAK-360, Placebo.
Кому может быть актуально
Состояния в реестре: Narcolepsy Type 2. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США, Китай, Франция, Италия, Япония +2
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants With Narcolepsy Without Cataplexy (NT2)

Обзор

Narcolepsy without cataplexy or Narcolepsy Type 2 (NT2) is a lifelong condition that makes people very sleepy during the day, regardless of how much sleep they get at night. People with NT2 may fall asleep suddenly, have trouble staying awake during the day, or may not be able to sleep well at night. They may have difficulty thinking clearly, paying attention, or remembering things, during the day. These symptoms can make daily activities like driving, working, or caring for their families challenging, impacting their quality of life. 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 NT2 tolerate it. Researchers also want to find out if TAK-360 can help people with NT2 stay awake and determine the right dosage needed to do that. Participants will be randomly (by chance, like drawing names from a hat) assigned to get either TAK-360 or placebo in the treatment period. The placebo is a pill that 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 Event (TEAE) [Срок оценки: Up to 15 Weeks]
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 Mean Sleep Latency on the Maintenance of Wakefulness Test (MWT) [Срок оценки: Baseline, Week 4]

Критерии участия

Критерии включения

  • The participant weighs greater than equal or 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 NT2.

Критерии исключения

  • The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) other than NT2.
  • 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 (HCV) 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 (<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 · 31 центр
  • Takeda Site 36 — Auburn
  • Takeda Site 39 — Chandler
  • Takeda Site 40 — Chula Vista
  • Takeda Site 14 — Redwood City
  • Takeda Site 10 — Santa Ana
  • Takeda Site 1 — Colorado Springs
  • Takeda Site 48 — Bradenton
  • Takeda Site 13 — Brandon
  • … и ещё 23 центра
Япония · 8 центров
  • Takeda Site 24 — Kohoku-ku, Yokohama-Shi
  • Takeda Site 9 — Kumamoto
  • Takeda Site 53 — Isahaya-shi
  • Takeda Site 30 — Urasoe-Shi
  • Takeda Site 20 — Shinjuku-ku
  • Takeda Site 26 — Sumida-Ku
  • Takeda Site 52 — Fukuoka
  • Takeda Site 12 — Yodogawa-ku, Osaka-shi
Китай · 4 центра
  • Takeda Site 28 — Пекин
  • Takeda Site 29 — Гуанчжоу
  • Takeda Site 51 — Changchun
  • Takeda Site 27 — Шанхай
Италия · 3 центра
  • Takeda Site 22 — Rome
  • Takeda Site 31 — Verona
  • Takeda Site 23 — Bologna
South Korea · 3 центра
  • Takeda Site 16 — Junggu
  • Takeda Site 19 — Suwon
  • Takeda Site 21 — Seoul
Франция · 2 центра
  • Takeda Site 17 — Montpellier
  • Takeda Site 15 — Paris
Испания · 1 центр
  • Takeda Site 18 — Madrid

Идентификаторы

NCT: NCT06952699 · TAK-360-2001 · 2024-517711-70-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗