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NCT06809803PHASE2Recruiting

Extended-release Sodium Oxybate in Children

Stanford University

Start Date

10/27/2025

Completion Date

7/1/2027

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

Age Range: 7 years to 17 years

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

Interventions

DRUG

Extended-release sodium oxybate

DRUG

Non-extended-release oxybates

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Conditions

Narcolepsy Type 1 (NT 1)

Locations

Stanford University

Redwood City, California 94063

United States