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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Harmony Biosciences Management, Inc.
Study ID
NCT07500090
Phase
PHASE3
Status
Recruiting
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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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Key Dates

First listed
Mar 30, 2026
Start date
Mar 16, 2026
Status verified
Jun 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
  • Placebo Comparator: Double-blind Treatment Period Placebo
    Matching placebo tablets administered once daily in the morning upon wakening
  • Experimental: Open-label Extension Period HBS-301
    HBS-301 tablets administered once daily in the morning upon wakening

Primary Outcome Measure

Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks) ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Sleep Disorders Center of AlabamaBirminghamAlabama35213
Robert Doekel, MD
[email protected]
205-599-1020
Stanford Center for Sleep MedicineRedwood CityCalifornia94063
Oliver Sum-Ping, MD (PRINCIPAL_INVESTIGATOR)
Santa Monica Clinical TrialsSanta MonicaCalifornia90404
Jualynda Smith
Daniel Norman, MD (PRINCIPAL_INVESTIGATOR)
Alpine Clinical Research Center, Inc.BoulderColorado80301
John R Harsh, PhD
[email protected]
601-520-1333
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)
Sleep Practitioners, LLCMaconGeorgia31210
Charles Wells, MD
[email protected]
478-745-5779
Phillip NowlinStockbridgeGeorgia30281
Phillip Nowlin, MD
Revive Research InstituteSouthfieldMichigan48975
Syed Muhammad Talib Rizvi Raza, MD (PRINCIPAL_INVESTIGATOR)
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
Suburban Research AssociatesWest ChesterPennsylvania19380
Omer Abdullah, MD (PRINCIPAL_INVESTIGATOR)
Respiratory SpecialistsWyomissingPennsylvania19610
Alex Platt, MD
Alec Platt, MD (PRINCIPAL_INVESTIGATOR)
Lowcountry Lung and Critical Care, PACharlestonSouth Carolina29406
Thomas D. Kaelin, DO
[email protected]
843-572-8545
Bogan Sleep Consultants, LLCColumbiaSouth Carolina29201
Richard Bogan, MD
[email protected]
803-251-3093
K2 Medical ResearchNashvilleTennessee37204
Auchaia Farley, PA
Joshua Lennon, MD (PRINCIPAL_INVESTIGATOR)
Southwest Family Medicine AssociatesDallasTexas75235
Chrisette Dharma, MD
[email protected]
214-393-2940
HAS ResearchSan AntonioTexas78240
Hernan A Salazar, DO (PRINCIPAL_INVESTIGATOR)
West Virginia UniversityMorgantownWest Virginia26506
Mouhannad Azzouz
[email protected]
304-598-4000

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