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Study identifier: NCT07675135 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

Condition: EDS · Cataplexy · Fatigue  ·  Sponsor: Harmony Biosciences Management, Inc.

PhasePhase 3
Planned participants258
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 description comes directly from the study's public registry record.

Talk to the study team

Michelle Manuel  ·  847-903-4610  ·  clinicaltrials@harmonybiosciences.com

Katie Wilmsen  ·  443-309-5556  ·  clinicaltrials@harmonybiosciences.com

Always discuss trial participation with your own doctor first.

Locations (14)

Phoenix Medical Group, PCPeoria, Arizona, United StatesRecruiting
Santa Monica Clinical TrialsLos Angeles, California, United StatesRecruiting
Alpine Clinical Research Center, IncBoulder, Colorado, United StatesRecruiting
PharmaDev Clinical Research Institute, LLCMiami, Florida, United StatesRecruiting
Central Florida Pediatric Sleep Disorders InstituteWinter Park, Florida, United StatesRecruiting
Neurotrials Research IncAtlanta, Georgia, United StatesRecruiting
Sleep Practitioners, LLCMacon, Georgia, United StatesRecruiting
Intrepid Research, LLCCincinnati, Ohio, United StatesRecruiting
Respiratory SpecialistsWyomissing, Pennsylvania, United StatesRecruiting
Lowcountry Lung and Critical Care PACharleston, South Carolina, United StatesRecruiting
Bogan Sleep Consultants, LLCColumbia, South Carolina, United StatesRecruiting
Southwest Family MedicineDallas, Texas, United StatesRecruiting

+ 2 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07675135