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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Harmony Biosciences Management, Inc.
Study ID
NCT07500090
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Idiopathic Hypersomnia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 idiopathic hypersomnia (IH) symptoms, including excessive daytime sleepiness (EDS), sleep inertia, and fatigue in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH). The primary objective of this study is to evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms. Secondary objectives include evaluating the efficacy of HBS-301 compared with placebo in treating EDS, sleep inertia, and fatigue.

Key Dates

Start date
Mar 16, 2026
Status verified
Mar 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
248 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Double-Blind Treatment Period HBS-301
    HBS-301 tablets administered once daily in the morning upon wakening at least 1 hour before meals
  • Placebo Comparator: Double-blind Treatment Period Placebo
    Matching placebo tablets administered once daily in the morning upon wakening at least 1 hour before meals
  • Experimental: Open-label Extension Period HBS-301
    HBS-301 tablets administered once daily in the morning upon wakening at least 1 hour before meals

Primary Outcome Measure

To evaluate the efficacy of HBS-301 compared with placebo in treating IH symptoms [ Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks) ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Santa Monica Clinical TrialsSanta MonicaCalifornia90404
Jualynda Smith
Daniel Norman, MD (PRINCIPAL_INVESTIGATOR)
PharmDev Research Institute, LLCMiamiFlorida33176
Lisbet Machado Cordova, APRN
Edward Mezerhane, MD (PRINCIPAL_INVESTIGATOR)
Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)Winter ParkFlorida32789
Akinyemi Ajayi, MD
NeuroTrials Research Inc.AtlantaGeorgia30328
Dennis Lacey, MD
Melody
Dennis Lacey, MD (PRINCIPAL_INVESTIGATOR)
Phillip NowlinStockbridgeGeorgia30281
Phillip Nowlin, MD
St. Luke's Hospital, Sleep Medicine and Research CenterChesterfieldMissouri63017
Michael McLeland, PhD
Michael McLeland, PhD (PRINCIPAL_INVESTIGATOR)
Clinical Research of GastoniaGastoniaNorth Carolina28054
Melissa Lanham
[email protected]
704-675-7144
Madeline Gibson
[email protected]
704-675-7144
Anup Banerjee, MD (PRINCIPAL_INVESTIGATOR)
Stern Research Partners, LLCHuntersvilleNorth Carolina28078
Felix Kurniawan
[email protected]
704-248-0000
Thomas Stern, MD (PRINCIPAL_INVESTIGATOR)
David Kudrow, MDMorrisvilleNorth Carolina27560
David Kudrow, MD
Respiratory SpecialistsWyomissingPennsylvania19610
Alex Platt, MD
Alec Platt, MD (PRINCIPAL_INVESTIGATOR)
K2 Medical ResearchNashvilleTennessee37204
Auchaia Farley, PA
Joshua Lennon, MD (PRINCIPAL_INVESTIGATOR)
West Virginia UniversityMorgantownWest Virginia26506
Mouhannad Azzouz
[email protected]
304-598-4000

Find similar trials in Santa Monica, CA

By research site
Santa Monica Clinical Trials· Santa Monica, CAPharmDev Research Institute, LLC· Miami, FLCentral Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)· Winter Park, FLNeuroTrials Research Inc.· Atlanta, GAPhillip Nowlin· Stockbridge, GASt. Luke's Hospital, Sleep Medicine and Research Center· Chesterfield, MO

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