Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07500090 | A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) | PHASE3 | RECRUITING | 248 | — | — | Mar 16, 2026 | Oct 1, 2028 | Mar 30, 2026 | 12 | United States |
Change in severity of IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale
| Arm | Type | Description |
|---|---|---|
| Double-Blind Treatment Period HBS-301 | EXPERIMENTAL | HBS-301 tablets administered once daily in the morning upon wakening at least 1 hour before meals |
| Double-blind Treatment Period Placebo | PLACEBO_COMPARATOR | Matching placebo tablets administered once daily in the morning upon wakening at least 1 hour before meals |
| Open-label Extension Period HBS-301 | EXPERIMENTAL | HBS-301 tablets administered once daily in the morning upon wakening at least 1 hour before meals |
| Name | Type | Description |
|---|---|---|
| HBS-301 tablet | DRUG | HBS-301 tablet |
| Placebo | DRUG | Placebo tablet |
Inclusion Criteria: * Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT); and if applicable, an actigraphy report...