Extended-release sodium oxybate for children with narcolepsy type 1
Compares a once-nightly sodium oxybate with other oxybates in children with narcolepsy type 1.
Key facts
- Who runs it
- Stanford University
- Where
- Redwood City, United StatesSee the site
- Trial code
- Registry title
- Extended-release Sodium Oxybate in Children
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 36 people, planned
- Started
- 27 Oct 2025
- Expected to end
- Jul 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Extended-release sodium oxybate
- Non-extended-release oxybates
- Record updated
- 6 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children aged 7 to 17 with narcolepsy type 1 who are cared for at the Stanford Sleep Clinic. It compares extended-release sodium oxybate with non-extended-release oxybates.
- Age
- 7 Years to 17 Years
- Sex
- All sexes can join.
- Disease stage
- A documented diagnosis of narcolepsy type 1, with sleepiness. The diagnosis must be backed by one of these: a spinal fluid marker (hypocretin-1) at a specific level, a history of sudden loss of muscle control (cataplexy), a specific genetic marker, or a sleep study with a typical pattern.
- Earlier treatment
- Participants must be on a stable dose of their medications.
- Biomarker or test result
- One way to show the diagnosis is a spinal fluid hypocretin-1 level at a specific level, or a specific genetic marker for narcolepsy. These are options, not all required.
Main reasons for not taking part
- Mental health problems that are not under control
- Other sleep problems that are not under control and cause sleepiness
- Current thoughts of ending one's life, or sadness or loss of interest
- Current illegal drug use problem
- Being pregnant now
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- 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
Who cannot take part
- Currently having a problem with illegal drug use
- 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 pregnant
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 7 and 17 years old?
Where in United States
- Stanford UniversityRedwood City, United StatesContact: Miran ChoTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Extended-release sodium oxybateTreatment being tested
Participants in this arm will take extended-release sodium oxybate
Treatment: Extended-release sodium oxybate and Non-extended-release oxybates
- Non-extended-release oxybatesExisting treatment, for comparison
Participants in this arm will take non-extended-release sodium oxybate
Treatment: Extended-release sodium oxybate and Non-extended-release oxybates
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children
- Plain-language title
- Extended-release sodium oxybate for children with narcolepsy type 1Generated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06809803, who can take part
- Record updated
- 6 November 2025