A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
Public ClinicalTrials.gov record NCT07500090. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT07500090
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Industry
- Enrollment
- 248 participants
Conditions and interventions
Conditions
Interventions
- HBS-301 tablet Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 15, 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2028
- Last update posted
- Mar 29, 2026
2026 – 2028
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Santa Monica Clinical Trials | Santa Monica | California | 90404 | Recruiting |
| PharmDev Research Institute, LLC | Miami | Florida | 33176 | Recruiting |
| Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC) | Winter Park | Florida | 32789 | Recruiting |
| NeuroTrials Research Inc. | Atlanta | Georgia | 30328 | Recruiting |
| Phillip Nowlin | Stockbridge | Georgia | 30281 | Recruiting |
| St. Luke's Hospital, Sleep Medicine and Research Center | Chesterfield | Missouri | 63017 | Recruiting |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | Recruiting |
| Stern Research Partners, LLC | Huntersville | North Carolina | 28078 | Recruiting |
| David Kudrow, MD | Morrisville | North Carolina | 27560 | Recruiting |
| Respiratory Specialists | Wyomissing | Pennsylvania | 19610 | Recruiting |
| K2 Medical Research | Nashville | Tennessee | 37204 | Recruiting |
| West Virginia University | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07500090, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2026 · Synced May 19, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07500090 live on ClinicalTrials.gov.