A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
Key facts
- Where
- Abington, Ardmore, Atlanta, Austin, Birmingham, Boulder, Charleston, Chesterfield, Cincinnati, Cleveland, Colorado Springs, Columbia, Dallas, Danville, Denver, East Providence, Fort Wayne, Gastonia, Glenview, Huntersville, Kansas City, Lancaster, Los Angeles, Macon, Madison, McKinney, Miami, Middletown, Mobile, Morgantown, Nashville, New Hyde Park, Novi, Peoria, Pittsburgh, Redwood City, Rincon, San Antonio, San Francisco, San Ramon, Southfield, Spokane, Sterling Heights, Stockbridge, Sugar Land, Williamsburg, Winter Park, and Wyomissing, United StatesSee the 51 sites
- Phase
- Phase 3
Where in United States
- Abington Neurological AssociatesAbington, United StatesContact: Rachel GrossmanTaking people
- Neurology CareArdmore, United StatesContact: Maaz GhaniNot yet recruiting
- NeuroTrials Research IncAtlanta, United StatesContact: Shriya ParekhTaking people
- Aayus ResearchAustin, United StatesContact: Maria-Fernanda GameroTaking people
- Sleep Disorders Center of AlabamaBirmingham, United StatesContact: Joseph WrightNot yet recruiting
- Alpine Clinical Research Center, IncBoulder, United StatesContact: Federica BrescianiTaking people
- Lowcountry Lung and Critical Care, PACharleston, United StatesContact: Courtney ArnoldTaking people
- Medical University of South CarolinaCharleston, United StatesContact: Brooke CameronNot yet recruiting
- St. Lukes Sleep Medicine and Research CenterChesterfield, United StatesContact: Kimberly Allen-BowzerTaking people
- Intrepid Research, LLCCincinnati, United StatesContact: Tiffany SchiraTaking people
- The Cleveland Clinic FoundationCleveland, United StatesContact: Alex PiczerNot yet recruiting
- Delta Waves LLCColorado Springs, United StatesContact: Emma GallagherTaking people
- Bogan Sleep Consultants, LLCColumbia, United StatesContact: Lorraine PottsTaking people
- Southwest Family MedicineDallas, United StatesContact: Safia ShaikhTaking people
- Geisinger Medical CenterDanville, United StatesContact: Cheryl PysherNot yet recruiting
- Research Carolina Elite LLCDenver, United StatesContact: Heather Micun, RMA, CRCNot yet recruiting
- Infinity Medical Research, Inc.East Providence, United StatesContact: Patricia MelloNot yet recruiting
- Fort Wayne Neurological CenterFort Wayne, United StatesContact: James StevensNot yet recruiting
- Clinical Research of GastoniaGastonia, United StatesContact: Melissa LanhamTaking people
- Northshore University HealthSystemGlenview, United StatesContact: Anna PhamNot yet recruiting
- Stern Research PartnersHuntersville, United StatesContact: Felix KurniawanTaking people
- University of Kansas Hospital Main CampusKansas City, United StatesContact: Whitney TheisNot yet recruiting
- West Coast Pulmonary & Sleep Disorders CenterLancaster, United StatesContact: Stephanie NavaNot yet recruiting
- Santa Monica Clinical TrialsLos Angeles, United StatesContact: Samantha MontanezTaking people
- Sleep Practitioners, LLCMacon, United StatesContact: Noelle WilliamsTaking people
- University of Wisconsin - MadisonMadison, United StatesContact: Ahmad AllenNot yet recruiting
- Metroplex Pulmonary and Sleep CenterMcKinney, United StatesContact: Rupa KrishnaNot yet recruiting
- PharmaDev Clinical Research Institute, LLCMiami, United StatesContact: Rolando RodriguezTaking people
- Patient First MDMiddletown, United StatesContact: Avraham TuvyNot yet recruiting
- Springhill Medical CenterMobile, United StatesContact: Kennedy GreenNot yet recruiting
- West Virginia University HospitalMorgantown, United StatesContact: Lauren ChaseNot yet recruiting
- K2 Medical Research - NashvilleNashville, United StatesContact: Francesca McKayNot yet recruiting
- Northwell Health Physician PartnersNew Hyde Park, United StatesContact: Kirendra PasramNot yet recruiting
- Henry Ford Medical CenterNovi, United StatesContact: Michaela MogleNot yet recruiting
- OSF St Francis Medical CenterPeoria, United StatesContact: Kimberly HartwigNot yet recruiting
- Phoenix Medical Group, PCPeoria, United StatesContact: Daniel KasenovichTaking people
- University of PittsburghPittsburgh, United StatesContact: Steve SwangerNot yet recruiting
- Stanford Center for Sleep Sciences and MedicineRedwood City, United StatesContact: Sara LombaTaking people
- Southeast Lung Associates ResearchRincon, United StatesContact: Lisa RodnickiTaking people
- HASresearchSan Antonio, United StatesContact: Kimberly RosalesNot yet recruiting
- Sleep Therapy Research CenterSan Antonio, United StatesContact: Erin MarshallTaking people
- University of California San FranciscoSan Francisco, United StatesContact: Kyra PowersNot yet recruiting
- Trial Site SolutionsSan Ramon, United StatesContact: Phil StraussTaking people
- Revive Research Institute, IncSouthfield, United StatesContact: Abhishek DhillonTaking people
- Sleep and Performance Research CenterSpokane, United StatesContact: Olivia BrooksTaking people
- Clinical Neurophysiology ServicesSterling Heights, United StatesContact: Jessica AustinTaking people
- Clinical Research Institute StockbridgeStockbridge, United StatesContact: Beverley JenkinsTaking people
- Tricoastal Narcolepsy and Sleep Disorders CenterSugar Land, United StatesContact: Natalia DubockTaking people
- TPMG Clinical ResearchWilliamsburg, United StatesContact: Gabrielle LandNot yet recruiting
- Florida Pediatric Sleep Disorders InstituteWinter Park, United StatesContact: Heidi PatenaudeTaking people
- Berks Schuylkill Respiratory SpecialistsWyomissing, United StatesContact: Lisa HillTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Harmony Biosciences Management, Inc.
- Trial code
- NCT07675135EU 2025-523821-17-00
- Record updated
- 27 August 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy Followed by an Open-label Extension
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.
Inclusion: Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years; Has EDS; 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 (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.
Exclusion: 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 (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening); Has hypersomnia due to another medical disorder; Has any history of bipolar disorder or psychosis; Has acute or chronic liver disease or a history of moderate or severe hepatic impairment; Has a body surface area-corrected estimated glomerular filtration rate (eGFR) <60 mL/min; Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).