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NCT07675135 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
A Phase 3 study, sponsored by Harmony Biosciences Management.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 258
- Enrollment target
NCT07675135 is a Phase 3 study that is actively recruiting participants, run by Harmony Biosciences Management. The registered enrollment target is 258 participants.
The verdict
NCT07675135, a Phase 3 study, is actively recruiting participants, sponsored by Harmony Biosciences Management.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 258 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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
Interventions
- OTHER Placebo
- DRUG HBS-301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2026-06-04 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07675135
The ClinicalTrials.gov registry entry for NCT07675135 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 258 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.
NCT07675135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07675135 about?
NCT07675135 is a clinical study titled "A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy". 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 treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolep...
What is the current status of trial NCT07675135?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 258 participants. The study started on 2026-06-04. Estimated completion is 2027-11.
What interventions are being tested in trial NCT07675135?
The interventions under investigation include: Placebo (OTHER), HBS-301 (DRUG).
Who is sponsoring clinical trial NCT07675135?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
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