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Also known as Extended-release sodium oxybate
oxybate · 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 ...
Oxybate, also known as extended-release sodium oxybate, is being investigated for the treatment of Narcolepsy Type 1 (NT1) in children. It is a small molecule in the neurology therapeutic area. The drug is currently in Phase 2 clinical development and is not yet approved for this use.
Oxybate is a small molecule being studied for Narcolepsy Type 1 (NT1). The specific molecular target or target class has not been disclosed in the available information. The drug is being evaluated for its effects on symptoms of NT1 in a pediatric population.
Oxybate is being developed by Avadel Pharmaceuticals plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol AVDL. The company is conducting clinical trials to evaluate the safety and efficacy of extended-release sodium oxybate in children with Narcolepsy Type 1.
Oxybate is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is actively recruiting participants to study the extended-release formulation of sodium oxybate in children with Narcolepsy Type 1.
Oxybate is being studied in a Phase 2 clinical trial with the identifier NCT06809803, titled 'Extended-release Sodium Oxybate in Children'. This randomized, active-controlled study is recruiting 36 participants aged 7 years and older with Narcolepsy Type 1 in the United States. The trial is not double-blinded and is biomarker-selected.
Yes, oxybate is also known as extended-release sodium oxybate. This alternative name is used in clinical trial documentation and refers to the same drug product being developed by Avadel Pharmaceuticals for the treatment of Narcolepsy Type 1 in children.