Extended-release Sodium Oxybate in Children
Recruiting now · Phase 2
Conditions studied: Narcolepsy Type 1 (NT 1)
In brief
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.
Key facts
- Study ID
- NCT06809803
- Run by
- Stanford University
- People needed
- 36
- Starts
- 2025-10-27
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-11-06
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 having a problem with illegal drug use
- Currently pregnant
Where it is running
- Stanford University — Redwood City, California, United States (enrolling)
Full record on ClinicalTrials.gov
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