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RecruitingPhase 3

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

Harmony Biosciences Management, Inc. · NCT07675135

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
258
US sites recruiting
27
Study start
June 4, 2026
Record last updated
August 27, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: HBS-301; Placebo

Conditions: EDS; Cataplexy; Fatigue; Narcolepsy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
  • Has EDS.
  • If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As needed (PRN) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted.

Exclusion Criteria

  • Has hypersomnia due to another medical disorder.
  • Has a history of pitolisant use within 5 half-lives prior to Screening.
  • Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
  • Has any history of bipolar disorder or psychosis
  • Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
  • Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min.
  • Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).

Recruiting US locations

  • Phoenix Medical Group, PC

    Peoria, AZ 85381

    Site contact: Daniel Kasenovich · (623) 583-6542 · dkasenovich@phxresearch.com

  • Santa Monica Clinical Trials

    Los Angeles, CA 90025

    Site contact: Samantha Montanez · (310) 586-0843 · smontanez@smclinicaltrials.com

  • Stanford Center for Sleep Sciences and Medicine

    Redwood City, CA 94063

    Site contact: Sara Lomba · (650) 799-1565 · slomba@stanford.edu

  • Trial Site Solutions

    San Ramon, CA 94583

    Site contact: Phil Strauss · (925) 415-5353 · phil@sleepmds.com

  • Alpine Clinical Research Center, Inc

    Boulder, CO 80301

    Site contact: Federica Bresciani · (601) 520-1333 · fika@alpineresearch.com

  • Delta Waves LLC

    Colorado Springs, CO 80918

    Site contact: Emma Gallagher · (719) 262-9283 · egallagher@deltawaves.org

  • PharmaDev Clinical Research Institute, LLC

    Miami, FL 33176

    Site contact: Rolando Rodriguez · (305) 420-5636 · rrodriguez@pharmadevresearch.com

  • Florida Pediatric Sleep Disorders Institute

    Winter Park, FL 32789

    Site contact: Heidi Patenaude · (407) 898-2767 · heidi@ajayihealthcare.com

  • Neurotrials Research Inc

    Atlanta, GA 30328

    Site contact: Shriya Parekh · 404-851-9934 · sparekh@neurotrials.com

  • Sleep Practitioners, LLC

    Macon, GA 31210

    Site contact: Noelle Williams · (478) 745-5779 · nwilliams@sleeppractitioners.com

  • Southeast Lung Associates Research

    Rincon, GA 31326

    Site contact: Lisa Rodnicki · (912) 826-3927 · lisa.rodnicki@centricityresearch.com

  • Clinical Research Institute Stockbridge

    Stockbridge, GA 30281

    Site contact: Beverley Jenkins · (678) 782-5358 · bjenkins@clinicalresearchinstitute.us

  • Revive Research Institute, Inc

    Southfield, MI 48075

    Site contact: Abhishek Dhillon · (248) 564-1485 · adhillon@rev-research.com

  • Clinical Neurophysiology Services

    Sterling Heights, MI 48314

    Site contact: Jessica Austin · (586)-254-0707 · austinj@sleepandattentiondisorders.com

  • St. Lukes Sleep Medicine and Research Center

    Chesterfield, MO 63017

    Site contact: Kimberly Allen-Bowzer · (314) 205-6011 · SLHSleepResearch@stlukes-stl.com

  • Clinical Research of Gastonia

    Gastonia, NC 28054

    Site contact: Melissa Lanham · 704-675-7144 · mlanham@crgastonia.com

  • Stern Research Partners

    Huntersville, NC 28078

    Site contact: Felix Kurniawan · 704-659-0090 · felix@arsmnc.com

  • Intrepid Research, LLC

    Cincinnati, OH 45245

    Site contact: Tiffany Schira · (513) 977-8891 · tschira@intrepidresearch.md

  • Abington Neurological Associates

    Abington, PA 19001

    Site contact: Rachel Grossman · (215) 957-9250 · rachelgrossman.ana@gmail.com

  • Berks Schuylkill Respiratory Specialists

    Wyomissing, PA 19610

    Site contact: Lisa Hill · (610) 685-5864 · lhill@lungmd.net

  • Lowcountry Lung and Critical Care PA

    Charleston, SC 29406

    Site contact: Courtney Arnold · (843) 572-8545 · carnold@lowcountrylung.com

  • Bogan Sleep Consultants, LLC

    Columbia, SC 29201

    Site contact: Lorraine Potts · (803) 251-3093 · Lorraine.Potts@bogansleep.com

  • Aayus Research

    Austin, TX 78731

    Site contact: Maria-Fernanda Gamero · (803) 606-2052 · Maria@aayus.co

  • Southwest Family Medicine

    Dallas, TX 75235

    Site contact: Safia Shaikh · (469) 893-1242 · sshaikh@swmedicalgroup.com

  • Sleep Therapy & Research Center

    San Antonio, TX 78229

    Site contact: Erin Marshall · (210) 614-6000 · marshall.erin@sleeptrc.com

  • Tricoastal Narcolepsy and Sleep Disorders Center

    Sugar Land, TX 77478

    Site contact: Natalia Dubock · (832) 210-3850 · research@tricoastalsleep.com

  • Sleep and Performance Research Center

    Spokane, WA 99202

    Site contact: Olivia Brooks · (509) 358-7754 · olivia.brooks@wsu.edu

Study contacts (from the official record)

  • Michelle Manuel · 847-903-4610 · clinicaltrials@harmonybiosciences.com
  • Katie Wilmsen · 443-309-5556 · clinicaltrials@harmonybiosciences.com
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A Phase 3 Efficacy and Safety Study of HBS-301 in Participants… (NCT07675135) | Bored Studies