A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

Официальное название

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension

Обзор

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Подробное описание

Approximately 248 participants are planned for randomization in the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension (OLE) Period (1 year), and 30 days of safety follow-up.

Вмешательства

• Препарат HBS-301 tablet
  HBS-301 tablet
• Препарат Placebo
  Placebo tablet

Первичные конечные точки

• Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS) [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]

Вторичные конечные точки (12)

• Change in severity of IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale (IHSS) [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Change in sleep inertia as measured by the Sleep Inertia Questionnaire (SIQ) [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Change in severity of EDS as measured by the Epworth Sleepiness Scale [Срок оценки: Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)]
• Change in severity of IH symptoms as measured by the IHSS [Срок оценки: Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)]
• Change in severity of EDS as measured by the Clinical Global Impression of Severity (EDS) [Срок оценки: Baseline to end of Double-blind Treatment Period (8 weeks)]
• Change in severity of EDS as measured by the Patient Global Impression of Severity (EDS) [Срок оценки: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
• Improvement in severity of EDS as measured by the Patient Global Impression of Change (EDS) [Срок оценки: End of the Double-blind Treatment Period (8 weeks)]
• Change in severity of IH symptoms as measured by the Clinical Global Impression of Severity (IH) [Срок оценки: Baseline to end of Double-blind Treatment Period (8 weeks)]
• Change in severity of IH symptoms as measured by the Patient Global Impression of Severity (IH) [Срок оценки: Baseline to end of Double-blind Treatment Period (8 weeks)]
• Improvement in severity of IH symptoms as measured by the Patient Global Impression of Change (IH) [Срок оценки: Baseline to end of Double-blind Treatment Period (8 weeks)]
• Change in severity of sleep inertia as measured by the Patient Global Impression of Severity (Sleep Inertia) [Срок оценки: Baseline to end of Double-blind Treatment Period (8 weeks)]

Критерии участия

Критерии включения

• Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.
• Has EDS.
• Has moderate to very severe symptoms of IH.
• If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As-needed use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis is not permitted.

Критерии исключения

• Has hypersomnia due to another medical disorder.
• Has a history of pitolisant use within 5 half-lives prior to Screening.
• Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled.
• Has a history of moderate or severe hepatic impairment.
• Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
• Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).

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

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 22 центра

• Sleep Disorders Center of Alabama — Birmingham
• Stanford Center for Sleep Medicine — Redwood City
• Santa Monica Clinical Trials — Santa Monica
• Alpine Clinical Research Center, Inc. — Boulder
• PharmDev Research Institute, LLC — Miami
• Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, — Winter Park
• NeuroTrials Research Inc. — Atlanta
• Sleep Practitioners, LLC — Macon
• … и ещё 14 центров

Идентификаторы

NCT: NCT07500090 · HBS-301-CL-302 · 2025-523822-42-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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