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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523822-42-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Treatment Period HBS-301 | Experimental | HBS-301 tablets administered once daily in the morning upon wakening |
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| Double-blind Treatment Period Placebo | Placebo Comparator | Matching placebo tablets administered once daily in the morning upon wakening |
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| Open-label Extension Period HBS-301 | Experimental | HBS-301 tablets administered once daily in the morning upon wakening |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBS-301 tablet | Drug | HBS-301 tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS) | The ESS is an 8-item, 4-point rating scale. | Baseline to the end of the Double-blind Treatment Period (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to the end of the Double-blind Treatment Period (8 weeks) |
| Change in sleep inertia as measured by the Sleep Inertia Questionnaire (SIQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Wilmsen | Contact | 443-309-5556 | clinicaltrials@harmonybiosciences.com | |
| Michelle Manuel | Contact | 847-903-4610 | clinicaltrials@harmonybiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| David Seiden, MD | Harmony Biosciences Management, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Disorders Center of Alabama | Recruiting | Birmingham | Alabama | 35213 | United States |
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| Placebo | Drug | Placebo tablet |
|
The SIQ is a 22-item questionnaire that measures aspects of night and day sleep symptoms and the sleep inertia related to each. |
| 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. | 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. | 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. | 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) | The Clinical Global Impression of Severity (EDS) is a 5-item observer-rated scale that gauges the severity of a participant's EDS symptoms. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Throughout study (16 months including OLE) |
| Stanford Center for Sleep Medicine | Recruiting | Redwood City | California | 94063 | United States |
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| Santa Monica Clinical Trials | Recruiting | Santa Monica | California | 90404 | United States |
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| Alpine Clinical Research Center, Inc. | Recruiting | Boulder | Colorado | 80301 | United States |
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| PharmDev Research Institute, LLC | Recruiting | Miami | Florida | 33176 | United States |
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| Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC) | Recruiting | Winter Park | Florida | 32789 | United States |
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| NeuroTrials Research Inc. | Recruiting | Atlanta | Georgia | 30328 | United States |
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| Sleep Practitioners, LLC | Recruiting | Macon | Georgia | 31210 | United States |
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| Phillip Nowlin | Recruiting | Stockbridge | Georgia | 30281 | United States |
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| Revive Research Institute | Recruiting | Southfield | Michigan | 48975 | United States |
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| St. Luke's Hospital, Sleep Medicine and Research Center | Recruiting | Chesterfield | Missouri | 63017 | United States |
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| Clinical Research of Gastonia | Recruiting | Gastonia | North Carolina | 28054 | United States |
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| Stern Research Partners, LLC | Recruiting | Huntersville | North Carolina | 28078 | United States |
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| David Kudrow, MD | Recruiting | Morrisville | North Carolina | 27560 | United States |
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| Suburban Research Associates | Recruiting | West Chester | Pennsylvania | 19380 | United States |
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| Respiratory Specialists | Recruiting | Wyomissing | Pennsylvania | 19610 | United States |
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| Lowcountry Lung and Critical Care, PA | Recruiting | Charleston | South Carolina | 29406 | United States |
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| Bogan Sleep Consultants, LLC | Recruiting | Columbia | South Carolina | 29201 | United States |
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| K2 Medical Research | Recruiting | Nashville | Tennessee | 37204 | United States |
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| Southwest Family Medicine Associates | Recruiting | Dallas | Texas | 75235 | United States |
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| HAS Research | Recruiting | San Antonio | Texas | 78240 | United States |
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| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
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| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| D006970 | Disorders of Excessive Somnolence |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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