Extended-release Sodium Oxybate in Children

Last updated: November 5, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

2

Condition

Narcolepsy

Treatment

Extended-release sodium oxybate

Non-extended-release oxybates

Clinical Study ID

NCT06809803
75896
  • Ages 7-17
  • All Genders

Study 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 Criteria

Inclusion

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 bysleepiness and either: a spinal fluid marker for narcolepsy (hypocretin-1) at aspecific level, or a history of sudden loss of muscle control (cataplexy), or aparticular genetic marker for narcolepsy, or a sleep study showing a specific sleeppattern for narcolepsy.

  3. Parent(s), or guardian(s) have signed a consent form and the child must agree toparticipate.

  4. Participants are on a stable dose of medications

Exclusion

Exclusion Criteria:

Participants who have any of the following conditions will not be included in the study

  1. Uncontrolled mental health problems

  2. Uncontrolled sleep problems that lead to sleepiness.

  3. Currently having thought about ending one's life or sadness or loss of interest

  4. Currently having a problem with illegal drug use

  5. Currently pregnant

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: Extended-release sodium oxybate
Phase: 2
Study Start date:
October 27, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Stanford University

    Redwood City, California 94063
    United States

    Site Not Available

  • Stanford University

    Redwood City 5386834, California 5332921 94063
    United States

    Active - Recruiting

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