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Набира участници Фаза 3 NCT07455383

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Фаза 3 – широко изпитване преди одобрение
Заболявания: Narcolepsy Type 1

Спонсор: Alkermes, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
Кой може да участва
Inclusion Criteria: * Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level). 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 participant safety, interfere with any study assessment, or affect the participant's ability to complete the study. * Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study
Интервенции
ALKS 2680 Dose 1
DRUG
ALKS 2680 Dose 2
DRUG
Placebo
DRUG
Места на провеждане 3
САЩ (3)
Alkermes Investigational Site
Austin , Texas
Alkermes Investigational Site
Cincinnati , Ohio
Alkermes Investigational Site
Sugar Land , Texas
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
70 Years
Здрави доброволци
Не
Начална дата
06.04.2026
Крайна дата
01.06.2027
Регистрационен номер
NCT07455383
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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