Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523821-17-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
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 treating EDS, cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Approximately 258 participants are planned for randomization into 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 Period (1 year), and 30 days of safety follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-Blind Treatment Period HBS-301 | Experimental | HBS-301 tablets administered once daily in the morning upon wakening |
|
| Double-blind Treatment Period Placebo | Placebo Comparator | Matching placebo tablets administered once daily in the morning upon wakening |
|
| Open-Label Extension Period HBS-301 | Experimental | HBS-301 tablets administered once daily in the morning upon wakening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBS-301 | 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 end of Double-Blind Treatment Period (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weekly Rate of Cataplexy (WRC) in participants with an average WRC of ≥3 over 2 consecutive weeks at Screening | The WRC is the average number of cataplexy attacks per week. | End of the Double-Blind Treatment Period (8 weeks) |
| Change in sleepiness/wakefulness measured by the Maintenance of Wakefulness Test (MWT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle Manuel | Contact | 847-903-4610 | clinicaltrials@harmonybiosciences.com | |
| Katie Wilmsen | Contact | 443-309-5556 | clinicaltrials@harmonybiosciences.com |
| Name | Affiliation | Role |
|---|---|---|
| David Seiden, MD | Harmony Biosciences Management, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Medical Group, PC | Recruiting | Peoria | Arizona | 85381 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo tablet |
|
The MWT consists of a series of 20-minute to 40-minute trials spaced 2 hours apart and is used to measure an individual's ability to stay awake. |
| 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 (PROMIS-Fatigue-SF-7a) | The PROMIS-Fatigue-SF-7a is a 7-question, 5-point scale used to assess fatigue. | Baseline to end of Double-Blind Treatment Period (8 weeks) |
| Change in severity of EDS as measured by the ESS | The ESS is an 8-item, 4-point rating scale. | Baseline through Week 1 and through Week 2 of Titration Period (1 week and 2 weeks) |
| Onset of efficacy of HBS-301 compared with placebo in treating cataplexy measured by WRC in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening | The WRC is the average number of cataplexy attacks per week. | 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 Change (EDS) | The Clinical Global Impression of Change (EDS) is a 7-point scale used to measure the improvement or worsening of the participant's EDS relative to a baseline. | 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 the 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. | Baseline to the end of the Double-blind Treatment Period (8 weeks) |
| Change in severity of cataplexy as measured by the Clinical Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening | The Clinical Global Impression of Severity (Cataplexy) is a 3-item observer-rated scale used to track cataplexy symptom changes. | Baseline to the end of the Double-blind Treatment Period (8 weeks) |
| Change in severity of cataplexy as measured by the Patient Global Impression of Severity (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening | The Patient Global Impression of Severity (Cataplexy) is a participant-reported assessment that gauges the severity of cataplexy symptoms. | Baseline to the end of the Double-blind Treatment Period (8 weeks) |
| Improvement in severity of cataplexy as measured by the Patient Global Impression of Change (Cataplexy) in participants with an average WRC of ≥3 over 2 consecutive weeks during Screening | The Patient Global Impression of Change (Cataplexy) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their cataplexy symptoms. | Baseline to the 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 to the end of Double-blind Treatment Period (8 weeks) |
| Change 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. | Baseline to the end of the Double-blind Treatment Period (8 weeks) |
| Change in severity of narcolepsy symptoms as measured by the Narcolepsy Severity Scale (for participants with NT1) or Narcolepsy Severity Scale-2 (for participants with NT2) | The Narcolepsy Severity Scale is a 15-item participant-reported questionnaire that assesses the severity and consequences of narcolepsy symptoms. | Baseline to the 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-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: Narcolepsy work productivity loss score | The Work Productivity and Activity Impairment: Narcolepsy 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 Open-label Extension) |
| Evaluate the pharmacokinetic concentrations of pitolisant and major identified metabolites | Pharmacokinetics is the study of how the body interacts with administered substances for the duration of exposure. | Throughout study (16 weeks) |
| Santa Monica Clinical Trials | Recruiting | Los Angeles | California | 90025 | United States |
|
| Alpine Clinical Research Center, Inc | Recruiting | Boulder | Colorado | 80301 | United States |
|
| PharmaDev Clinical Research Institute, LLC | Recruiting | Miami | Florida | 33176 | United States |
|
| Central Florida Pediatric Sleep Disorders Institute | Recruiting | Winter Park | Florida | 32789 | United States |
|
| Neurotrials Research Inc | Recruiting | Atlanta | Georgia | 30328 | United States |
|
| Sleep Practitioners, LLC | Recruiting | Macon | Georgia | 31210 | United States |
|
| Intrepid Research, LLC | Recruiting | Cincinnati | Ohio | 45245 | United States |
|
| Respiratory Specialists | Recruiting | Wyomissing | Pennsylvania | 19610 | United States |
|
| Lowcountry Lung and Critical Care PA | Recruiting | Charleston | South Carolina | 29406 | United States |
|
| Bogan Sleep Consultants, LLC | Recruiting | Columbia | South Carolina | 29201 | United States |
|
| Southwest Family Medicine | Recruiting | Dallas | Texas | 75235 | United States |
|
| Sleep Therapy & Research Center | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Sleep and Performance Research Center | Recruiting | Spokane | Washington | 99202 | United States |
|
| ID | Term |
|---|---|
| D002385 | Cataplexy |
| D005221 | Fatigue |
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| 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 |
Not provided
Not provided