Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Extended-release sodium oxybate, oxybate
Lumryz · 1 trial · 1 indication
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 ...