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Study identifier: NCT07500090 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

Condition: Idiopathic Hypersomnia  ·  Sponsor: Harmony Biosciences Management, Inc.

PhasePhase 3
Planned participants248
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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

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

Talk to the study team

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

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

Always discuss trial participation with your own doctor first.

Locations (22)

Sleep Disorders Center of AlabamaBirmingham, Alabama, United StatesRecruiting
Stanford Center for Sleep MedicineRedwood City, California, United StatesRecruiting
Santa Monica Clinical TrialsSanta Monica, California, United StatesRecruiting
Alpine Clinical Research Center, Inc.Boulder, Colorado, United StatesRecruiting
PharmDev Research Institute, LLCMiami, Florida, United StatesRecruiting
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)Winter Park, Florida, United StatesRecruiting
NeuroTrials Research Inc.Atlanta, Georgia, United StatesRecruiting
Sleep Practitioners, LLCMacon, Georgia, United StatesRecruiting
Phillip NowlinStockbridge, Georgia, United StatesRecruiting
Revive Research InstituteSouthfield, Michigan, United StatesRecruiting
St. Luke's Hospital, Sleep Medicine and Research CenterChesterfield, Missouri, United StatesRecruiting
Clinical Research of GastoniaGastonia, North Carolina, United StatesRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT07500090