A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HBS-301, Placebo.
- Who it may be relevant to
- Registry conditions: EDS, Cataplexy, Fatigue, Narcolepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Detailed 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 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.
Interventions
- Drug HBS-301
HBS-301 tablet - Other Placebo
Placebo tablet
Primary outcome measures
- Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS) [Time frame: Baseline to end of Double-Blind Treatment Period (8 weeks)]
Secondary outcome measures (12)
- Change in Weekly Rate of Cataplexy (WRC) in participants with an average WRC of ≥3 over 2 consecutive weeks at Screening [Time frame: End of the Double-Blind Treatment Period (8 weeks)]
- Change in sleepiness/wakefulness measured by the Maintenance of Wakefulness Test (MWT) [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 (PROMIS-Fatigue-SF-7a) [Time frame: Baseline to end of Double-Blind Treatment Period (8 weeks)]
- Change in severity of EDS as measured by the ESS [Time frame: 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 [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 Change (EDS) [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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: Baseline to the end of Double-blind Treatment Period (8 weeks)]
Eligibility criteria
Inclusion criteria
- 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 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 (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 14 centers
- Phoenix Medical Group, PC — Peoria
- Santa Monica Clinical Trials — Los Angeles
- Alpine Clinical Research Center, Inc — Boulder
- PharmaDev Clinical Research Institute, LLC — Miami
- Central Florida Pediatric Sleep Disorders Institute — Winter Park
- Neurotrials Research Inc — Atlanta
- Sleep Practitioners, LLC — Macon
- Intrepid Research, LLC — Cincinnati
- … and 6 more centers
Identifiers
NCT: NCT07675135 · HBS-301-CL-301 · 2025-523821-17-00