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

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Harmony Biosciences Management, Inc.
Study ID
NCT07675135
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • HBS-301 — DRUG
    HBS-301 tablet
  • Placebo — OTHER
    Placebo tablet

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 excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.

Key Dates

Start date
Jun 4, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
258 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 end of Double-Blind Treatment Period (8 weeks) ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Phoenix Medical Group, PCPeoriaArizona85381
Robert Orr, DO (PRINCIPAL_INVESTIGATOR)
Santa Monica Clinical TrialsLos AngelesCalifornia90025
Daniel Norman, MD (PRINCIPAL_INVESTIGATOR)
Alpine Clinical Research Center, IncBoulderColorado80301
John R Harsh, PhD (PRINCIPAL_INVESTIGATOR)
PharmaDev Clinical Research Institute, LLCMiamiFlorida33176
Edward Mezerhane, MD (PRINCIPAL_INVESTIGATOR)
Central Florida Pediatric Sleep Disorders InstituteWinter ParkFlorida32789
Akinyemi O Ajayi, MD (PRINCIPAL_INVESTIGATOR)
Neurotrials Research IncAtlantaGeorgia30328
Dennis Lacey
404-851-9934
Sleep Practitioners, LLCMaconGeorgia31210
Charles C Wells, Jr, MD (PRINCIPAL_INVESTIGATOR)
Intrepid Research, LLCCincinnatiOhio45245
Bruce C Corser, MD (PRINCIPAL_INVESTIGATOR)
Respiratory SpecialistsWyomissingPennsylvania19610
Alec Platt, MD (PRINCIPAL_INVESTIGATOR)
Lowcountry Lung and Critical Care PACharlestonSouth Carolina29406
Thomas D Kaelin Jr, DO (PRINCIPAL_INVESTIGATOR)
Bogan Sleep Consultants, LLCColumbiaSouth Carolina29201
Richard Bogan, MD (PRINCIPAL_INVESTIGATOR)
Southwest Family MedicineDallasTexas75235
Chrisette Dharma, MD (PRINCIPAL_INVESTIGATOR)
Sleep Therapy & Research CenterSan AntonioTexas78229
Nagwa Lamaie, MD (PRINCIPAL_INVESTIGATOR)
Sleep and Performance Research CenterSpokaneWashington99202
Devon Hansen, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Peoria, AZ

By research site
Phoenix Medical Group, PC· Peoria, AZSanta Monica Clinical Trials· Los Angeles, CAAlpine Clinical Research Center, Inc· Boulder, COPharmaDev Clinical Research Institute, LLC· Miami, FLCentral Florida Pediatric Sleep Disorders Institute· Winter Park, FLNeurotrials Research Inc· Atlanta, GA

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