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

Phase 3RecruitingNCT07500090

Harmony Biosciences Management, Inc.248 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

248

Conditions

Idiopathic Hypersomnia

Interventions

HBS-301 tabletDRUG

HBS-301 tablet

PlaceboDRUG

Placebo tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (42)

Outcomes

Primary Outcomes

Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)

The ESS is an 8-item, 4-point rating scale.

Time frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)

Secondary Outcomes

Change in severity of IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale (IHSS)

The IHSS is a 14-item questionnaire designed to measure IH symptoms.

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)

The SIQ is a 22-item questionnaire that measures aspects of night and day sleep symptoms and the sleep inertia related to each.

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

The PROMIS-Fatigue-SF-7a is a 7-question, 5-point scale used to assess fatigue.

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

The ESS is an 8-item, 4-point rating 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

The ESS is an 8-item, 4-point rating scale.

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)

Central Contacts

Katie Wilmsen

CONTACT

443-309-5556 clinicaltrials@harmonybiosciences.com

Michelle Manuel

CONTACT

847-903-4610 clinicaltrials@harmonybiosciences.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

RECRUITING

Phoenix Medical Group LLC

Peoria, Arizona, United States

RECRUITING

Stanford Center for Sleep Medicine

Redwood City, California, United States

RECRUITING

Trial Site Solutions

San Ramon, California, United States

RECRUITING

Santa Monica Clinical Trials

Santa Monica, California, United States

RECRUITING

Alpine Clinical Research Center, Inc.

Boulder, Colorado, United States

RECRUITING

Delta Waves LLC

Colorado Springs, Colorado, United States

RECRUITING

PharmDev Research Institute, LLC

Miami, Florida, United States

RECRUITING

Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)

Winter Park, Florida, United States

RECRUITING

NeuroTrials Research Inc.

Atlanta, Georgia, United States

RECRUITING

...and 32 more locations

The Clinical Global Impression of Severity (EDS) is a 5-item observer-rated scale that gauges the severity of a participant's EDS symptoms.

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)

The Patient Global Impression of Severity (EDS) is a participant-reported assessment that gauges the severity of a participant's EDS symptoms.

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)

The Patient Global Impression of Change (EDS) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their EDS symptoms.

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)

The Clinical Global Impression of Severity (IH) is a 3-item observer-rated scale used to track IH symptom changes.

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)

The Patient Global Impression of Severity (IH) is a participant-reported assessment that gauges the severity of a participant's IH symptoms.

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)

The Patient Global Impression of Change (IH) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their IH symptoms.

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)

The Patient Global Impression of Severity (Sleep Inertia) is a participant-reported assessment that gauges the severity of a participant's sleep inertia symptoms.

Time frame: Baseline to end of Double-blind Treatment Period (8 weeks)

Improvement in severity of sleep inertia as measured by the Patient Global Impression of Change (Sleep Inertia)

The Patient Global Impression of Change (Sleep Inertia) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their sleep inertia symptoms.

Time frame: End of the Double-blind Treatment Period (8 weeks)

Change in severity of fatigue as measured by the Patient Global Impression of Severity (Fatigue)

The Patient Global Impression of Severity (Fatigue) is a participant-reported assessment that gauges the severity of a participant's fatigue symptoms.

Time frame: Baseline of the end of the Double-blind Treatment Period (8 weeks)

Improvement in severity of fatigue as measured by the Patient Global Impression of Change (Fatigue)

The Patient Global Impression of Change (Fatigue) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their fatigue symptoms.

Time frame: End of the Double-blind Treatment Period (8 weeks)

Change in cognitive complaints as measured by the British Columbia Cognitive Complaints Inventory

The British Columbia Cognitive Complaints Inventory is a participant-reported, 6-item, 4-point scale that assesses perceived cognitive difficulties.

Time frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)

Change in health-related quality of life as measured by the Short Form Health Survey-36 physical and mental component summaries

The Short Form-36 includes 36 questions across 8 health domains to measure a participant's functional health and well-being.

Time frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)

Change in work productivity as measured by the Work Productivity and Activity Impairment: Idiopathic Hypersomnia Work Productivity loss score

The Work Productivity and Activity Impairment: Idiopathic Hypersomnia questionnaire is a 6-item scale used to measure impairments over 7 days.

Time frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)

Incidence of treatment-emergent adverse events

A treatment-emergent adverse event is any adverse event reported after the first dose of study drug and up to 30 days after final dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug and up to 30 days after final dose of study drug.

Time frame: Throughout study (16 months including OLE)