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Набира участници Фаза 2 NCT06843590

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Idiopathic Hypersomnia

Спонсор: Alkermes, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets
Кой може да участва
Inclusion Criteria: * Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits. * Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle * Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study * Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1 * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Места на провеждане 8
Австралия (1)
Alkermes Investigator Site
Sydney , New South Wales
Белгия (1)
Alkermes Investigator Site
Alken
Чехия (1)
Alkermes Investigator Site
Prague
Франция (1)
Alkermes Investigator Site
Bordeaux , Gironde
Италия (1)
Alkermes Investigator Site
Bologna
Нидерландия (1)
Alkermes Investigator Site
Zwolle
Испания (1)
Alkermes Investigator Site
Barcelona
САЩ (1)
Alkermes Investigator Site
Cullman , Alabama
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
22.05.2025
Крайна дата
01.06.2026
Регистрационен номер
NCT06843590
Източник
anzctr
Запитване за медицински туризъм

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