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RecruitingPhase 3

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

Harmony Biosciences Management, Inc. · NCT07500090

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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
248
US sites recruiting
40
Study start
March 16, 2026
Record last updated
September 14, 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 adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Being studied: HBS-301 tablet; Placebo

Conditions: Idiopathic Hypersomnia

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 IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.
  • Has EDS.
  • Has moderate to very severe symptoms of IH.
  • 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 use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis 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.
  • Has a history of moderate or severe hepatic impairment.
  • Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min.
  • Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).

Recruiting US locations

  • Sleep Disorders Center of Alabama

    Birmingham, AL 35213

    Site contact: Joseph Wright · 205-599-1020 · jwright@sleepalabama.com

  • Phoenix Medical Group LLC

    Peoria, AZ 85381

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

  • Stanford Center for Sleep Medicine

    Redwood City, CA 94063

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

  • Trial Site Solutions

    San Ramon, CA 04583

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

  • Santa Monica Clinical Trials

    Santa Monica, CA 90404

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

  • Alpine Clinical Research Center, Inc.

    Boulder, CO 80301

    Site contact: Frederica Bresciani · 601-520-1333 · fika@alpineresearch.com

  • Delta Waves LLC

    Colorado Springs, CO 80918

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

  • PharmDev Research Institute, LLC

    Miami, FL 33176

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

  • Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)

    Winter Park, FL 32789

    Site contact: Heidi Patenube · 407-898-2767 · heidi@ajayhealthcare.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: Beverly Jenkins · 678-782-5358 · bjenkins@clinicalresearchinstitute.us

  • Fort Wayne Neurological Center

    Fort Wayne, IN 46804

    Site contact: Patti Case · 704-659-0090 · pcase@iuhealth.org

  • Revive Research Institute

    Southfield, MI 48975

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

  • Clinical Neuropsychology Services

    Sterling Heights, MI 48314

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

  • St. Luke's Hospital, 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, LLC

    Huntersville, NC 28078

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

  • David Kudrow, MD

    Morrisville, NC 27560

    Site contact: Victoria Taylor · 984-377-3737 · HarmonyIHPEC@science37.com

  • Neuroscience Research Center, LLC

    Canton, OH 44718

    Site contact: Kellie McCabe · 330-244-2542 · kelliem@neurocarecenter.com

  • Intrepid Research

    Cincinnati, OH 45245

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

  • Neurology Care

    Ardmore, OK 73401

    Site contact: Maaz Ghani · mghani@sunbeamresearch.com

  • Abington Neurological Associates

    Abington, PA 19001

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

  • Suburban Research Associates

    West Chester, PA 19380

    Site contact: Carol McDevitt · 610-891-9024 · cmcdevitt@suburbanresearch.com

  • Berks Schuylkill Respiratory Specialists

    Wyomissing, PA 19610

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

  • Infinity Medical Research Inc.

    East Providence, RI 02914

    Site contact: Patricia Mello · 508-998-3041 · pmello@infinitymedicalresearch.com

  • 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

  • K2 Medical Research

    Nashville, TN 37204

    Site contact: Francesca McKay · 615-208-5252 · francesca.mckay@k2med.com

  • Aayus Research

    Austin, TX 78731

    Site contact: Maria-Fernanda Gamero · 803-606-2052 · Maria@aayus.com

  • Southwest Family Medicine Associates

    Dallas, TX 75235

    Site contact: Safia Shaikh · 493-893-1242 · sshaikh@swmedicalgroup.com

  • Metroplex Pulmonary and Sleep Center

    McKinney, TX 75069

    Site contact: Rupa Krishna · 972-838-1892 · rkrishna@mpsleepcenter.com

  • Sleep Therapy and Research Center

    San Antonio, TX 30328

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

  • HAS Research

    San Antonio, TX 78240

    Site contact: Kimberly Rosales · 210-614-7711 · kimberly.rosales@hasresearch.com

  • Tricoastal Narcolepsy and Sleep Disorders Center

    Sugar Land, TX 77478

    Site contact: Natalia Dubok · 832-210-3850 · research@tricoastalsleep.com

  • TPMG Clinical Research

    Williamsburg, VA 23188

    Site contact: Gabrielle Land · 757-707-3503 · gabrielle.land@tpmgpc.com

  • Washington State University Sleep and Performance Center

    Spokane, WA 99210

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

  • West Virginia University

    Morgantown, WV 26506

    Site contact: Lauren Chase · 304-598-4000

  • University of Washington

    Madison, WI 53792

    Site contact: Ahmad Allen · 608-232-3333 · aallen45@wisc.edu

Study contacts (from the official record)

  • Katie Wilmsen · 443-309-5556 · clinicaltrials@harmonybiosciences.com
  • Michelle Manuel · 847-903-4610 · clinicaltrials@harmonybiosciences.com
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A Phase 3 Efficacy and Safety Study of HBS-301 in Participants… (NCT07500090) | Bored Studies