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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 is a Phase 3 study that is actively recruiting participants, run by Harmony Biosciences Management. The registered enrollment target is 248 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07500090
The ClinicalTrials.gov registry entry for NCT07500090 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Harmony Biosciences Management, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07500090 reports 0 study locations.
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.
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