Идёт набор NCT07540897

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

Фаза III С лечением Narcolepsy Type 1

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: ALKS 2680 Dose 1, ALKS 2680 Dose 2, Placebo.
Кому может быть актуально: Состояния в реестре: Narcolepsy Type 1. 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, Канада
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 Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 304)

Обзор

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.

Вмешательства

Препарат ALKS 2680 Dose 1
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Препарат ALKS 2680 Dose 2
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Препарат Placebo
Participants will receive placebo tablets, daily, orally for 12 weeks

Первичные конечные точки

Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level [Срок оценки: Baseline to Week 12]

Вторичные конечные точки (9)

Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level [Срок оценки: Baseline to Week 12]
Weekly cataplexy rate (WCR) at Week 12 by dose level [Срок оценки: Week 12]
Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression- Severity (PGI-S) scale(general disease) at Week 12 by dose level [Срок оценки: Week 12]
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level [Срок оценки: Baseline to Week 12]
Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level [Срок оценки: Baseline to Week 12]
Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baselineto Week 12 by dose level [Срок оценки: Baseline to Week 12]
Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level [Срок оценки: Week 12]
Change in Narcolepsy Severity Scale for Clinical Trials (NSS-CT) from baseline to Week 12 by dose level [Срок оценки: Baseline to Week 12]
Incidence of treatment emergent adverse events [Срок оценки: Baseline to Week 14]

Критерии участия

Критерии включения

Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level)

Критерии исключения

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.

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

Здоровые добровольцы: Нет