Home › Narcolepsy › NCT06809803

Extended-release Sodium Oxybate in Children

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

Who can join

Ages 7 to 17 · All sexes

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 loss of muscle control (cataplexy), or a particular genetic marker for narcolepsy, or a sleep study showing a specific sleep pattern for narcolepsy.
3. Parent(s), or guardian(s) have signed a consent form and the child must agree to participate.
4. Participants are on a stable dose of medications

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

About the study

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.

What is being tested

• Extended-release sodium oxybate (drug)
• Non-extended-release oxybates (drug)

Sponsor: Stanford University · Participants: 36 · Started: Oct 27, 2025

Contact the study team

• Miran Cho · Phone: 650-724-4149

Official record on ClinicalTrials.gov — NCT06809803

Locations in the U.S.

Conditions

• Narcolepsy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.