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
Conditions
Narcolepsy Type 1 (NT 1)
Locations
Stanford University
Redwood City, California 94063
United States