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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06809803 | Extended-release Sodium Oxybate in Children | PHASE2 | RECRUITING | 36 | — | — | Oct 27, 2025 | Jul 1, 2027 | Nov 6, 2025 | 1 | United States |
Participants will be asked at the end of the study whether participants prefer extended-release sodium oxybate vs sodium oxybate vs calcium, magnesium, potassium and sodium oxybates
| Arm | Type | Description |
|---|---|---|
| Extended-release sodium oxybate | EXPERIMENTAL | Participants in this arm will take extended-release sodium oxybate |
| Non-extended-release oxybates | ACTIVE_COMPARATOR | Participants in this arm will take non-extended-release sodium oxybate |
| Name | Type | Description |
|---|---|---|
| Extended-release sodium oxybate | DRUG | Participants will take Extended-release sodium Oxybate (Lumryz) 4.5-9 g oral suspension in approximately ⅓ cup of water orally once a day before bedtime. Dosage of Lumryz will be the same as the equivalent total dose of the Non-Extended-release Oxybate (Xywav or Xyrem) that participants use before starting the study |
| Non-extended-release oxybates | DRUG | Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and another dose 2-4 hours later) at the same dose of Xyrem or Xywav that participants use before starting the study will be continued to compare with Extended-release sodium Oxybate (Lumryz) |
Inclusion Criteria: 1. Participants must be under the care of a doctor at the Stanford Sleep Clinic. 2. Participants must have a documented diagnosis of narcolepsy type 1 shown by sleepiness and either: a spinal fluid marker for narcolepsy (hypocretin-1) at a specific level, or a history of sudden ...