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

ConditionIdiopathic Hypersomnia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHarmony Biosciences Management, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HBS-301 tablet

    Drug

    HBS-301 tablet

  • Placebo

    Drug

    Placebo tablet

Treatment groups

248 Participants
are divided into 3 treatment groups
Group A: Double-Blind Treatment Period HBS-301Experimental treatment 1 intervention
Group B: Double-blind Treatment Period PlaceboPlacebo comparator 1 intervention
Group C: Open-label Extension Period HBS-301Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harmony Biosciences Management, Inc.

Lead sponsor

Source ClinicalTrials.gov
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