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NCT07500090 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)
A Phase 3 study, sponsored by Harmony Biosciences Management.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 248
- Enrollment target
NCT07500090: Recruiting Phase 3 study, sponsored by Harmony Biosciences Management.
NCT07500090 is a Phase 3 study that is actively recruiting participants, run by Harmony Biosciences Management. The registered enrollment target is 248 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07500090, a Phase 3 study, is actively recruiting participants, sponsored by Harmony Biosciences Management.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 248 participants
- Enrollment target
Study Summary
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).
Primary Outcome
The ESS is an 8-item, 4-point rating scale.
Interventions
- DRUG Placebo
- DRUG HBS-301 tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2026-03-16 |
| Est. Completion | 2028-10 |
| Phase | Phase 3 |
What NCT07500090 shows while recruiting
NCT07500090 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07500090 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07500090 about?
NCT07500090 is a clinical study titled "A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)". 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).
What is the current status of trial NCT07500090?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 248 participants. The study started on 2026-03-16. Estimated completion is 2028-10.
What interventions are being tested in trial NCT07500090?
The interventions under investigation include: Placebo (DRUG), HBS-301 tablet (DRUG).
Who is sponsoring clinical trial NCT07500090?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07500090's enrollment target sits among peer trials
248 1266th of 2000 higher than 735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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