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Recruiting NCT07500090

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

Phase III Interventional Idiopathic Hypersomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HBS-301 tablet, Placebo.
Who it may be relevant to
Registry conditions: Idiopathic Hypersomnia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Detailed description

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.

Interventions

  • Drug HBS-301 tablet
    HBS-301 tablet
  • Drug Placebo
    Placebo tablet

Primary outcome measures

  • Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS) [Time frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
Secondary outcome measures (12)
  • Change in severity of IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale (IHSS) [Time frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
  • Change in sleep inertia as measured by the Sleep Inertia Questionnaire (SIQ) [Time frame: 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 [Time frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)]
  • Change in severity of EDS as measured by the Epworth Sleepiness Scale [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Baseline to end of Double-blind Treatment Period (8 weeks)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 22 centers
  • 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
  • … and 14 more centers

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗