Extended-release Sodium Oxybate in Children
Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children
Stanford University
36 participants
Oct 27, 2025
INTERVENTIONAL
Conditions
Summary
The main objectives of this study are to determine the treatment preferences of children with narcolepsy type 1 between Extended-release sodium oxybate and Non-extended-release oxybates (Sodium oxybate or a medication with the combination of Calcium, magnesium, potassium, and sodium oxybates). The study will also assess the safety, convenience, and tolerability of Extended-release sodium oxybate. Additionally, the researchers aim to assess how well Extended-release sodium oxybate works in treating narcolepsy type 1.
Eligibility
Inclusion Criteria4
- Participants must be under the care of a doctor at the Stanford Sleep Clinic.
- 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 loss of muscle control (cataplexy), or a particular genetic marker for narcolepsy, or a sleep study showing a specific sleep pattern for narcolepsy.
- Parent(s), or guardian(s) have signed a consent form and the child must agree to participate.
- Participants are on a stable dose of medications
Exclusion Criteria6
- Participants who have any of the following conditions will not be included in the study
- Uncontrolled mental health problems
- Uncontrolled sleep problems that lead to sleepiness.
- Currently having thought about ending one's life or sadness or loss of interest
- Currently having a problem with illegal drug use
- Currently pregnant
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Interventions
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
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)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06809803