๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-11

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) (NCT07500090)

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Harmony Biosciences Management, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 โ‰ฅ18 years) with idiopathic hypersomnia (IH).

Who can join: Review the eligibility criteria below.

Location: Sleep Disorders Center of Alabama โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (40 Sites)

Showing the first 25 of 40 sites.

  • Sleep Disorders Center of Alabama โ€” Birmingham, Alabama
  • Phoenix Medical Group LLC โ€” Peoria, Arizona
  • Stanford Center for Sleep Medicine โ€” Redwood City, California
  • Trial Site Solutions โ€” San Ramon, California
  • Santa Monica Clinical Trials โ€” Santa Monica, California
  • Alpine Clinical Research Center, Inc. โ€” Boulder, Colorado
  • Delta Waves LLC โ€” Colorado Springs, Colorado
  • PharmDev Research Institute, LLC โ€” Miami, Florida
  • Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC) โ€” Winter Park, Florida
  • NeuroTrials Research Inc. โ€” Atlanta, Georgia
  • Sleep Practitioners, LLC โ€” Macon, Georgia
  • Southeast Lung Associates Research โ€” Rincon, Georgia
  • Clinical Research Institute Stockbridge โ€” Stockbridge, Georgia
  • Fort Wayne Neurological Center โ€” Fort Wayne, Indiana
  • Revive Research Institute โ€” Southfield, Michigan
  • Clinical Neuropsychology Services โ€” Sterling Heights, Michigan
  • St. Luke's Hospital, Sleep Medicine and Research Center โ€” Chesterfield, Missouri
  • Clinical Research of Gastonia โ€” Gastonia, North Carolina
  • Stern Research Partners, LLC โ€” Huntersville, North Carolina
  • David Kudrow, MD โ€” Morrisville, North Carolina
  • Neuroscience Research Center, LLC โ€” Canton, Ohio
  • Intrepid Research โ€” Cincinnati, Ohio
  • Neurology Care โ€” Ardmore, Oklahoma
  • Abington Neurological Associates โ€” Abington, Pennsylvania
  • Suburban Research Associates โ€” West Chester, Pennsylvania

๐Ÿ“ž Contact the Study Coordinator

Phone: (205) 599-1020

Email: jwright@sleepalabama.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—