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Taking people in United StatesPhase 2

Extended-release Sodium Oxybate in Children

Key facts

Where
Redwood City, United StatesSee the site
Phase
Phase 2

Could this be for you?

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?

Source: NCT06809803, who can take part

Where in United States

  • Stanford UniversityRedwood City, United StatesContact: Miran ChoTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Stanford University
Trial code
NCT06809803
Record updated
6 November 2025
Original description
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.Read full original descriptionShow less

Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT06809803