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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07598708 | A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence | PHASE2 | RECRUITING | 222 | — | — | May 15, 2026 | Dec 31, 2027 | Jun 8, 2026 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Group A - Narcolepsy Type 1 (Dose 1) | EXPERIMENTAL | - |
| Group A - Narcolepsy Type 1 (Dose 2) | EXPERIMENTAL | - |
| Group A - Narcolepsy Type 1 (placebo) | PLACEBO_COMPARATOR | - |
| Group B - Narcolepsy Type 2 (Dose 1) | EXPERIMENTAL | - |
| Group B - Narcolepsy Type 2 (Dose 2) | EXPERIMENTAL | - |
| Group B - Narcolepsy Type 2 (placebo) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| cleminorexton | DRUG | Oral cleminorexton capsule |
| Placebo | DRUG | matching placebo capsule |
Key Inclusion Criteria: * 18-70 years of age * Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg/m\^2 (inclusive) * Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD...