Actively Recruiting
Extended-release Sodium Oxybate in Children
Led by Stanford University · Updated on 2025-11-06
36
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
A
Avadel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Extended-release Sodium Oxybate in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, a history of sudden loss of muscle control (cataplexy), a particular genetic marker for narcolepsy, or a sleep study showing a specific sleep pattern for narcolepsy.
- Parent(s) or guardian(s) must have signed a consent form and the child must agree to participate.
- Participants must be on a stable dose of medications.
You will not qualify if you...
- Uncontrolled mental health problems.
- Uncontrolled sleep problems that lead to sleepiness.
- Currently having thoughts about ending one's life or sadness or loss of interest.
- Currently having a problem with illegal drug use.
- Currently pregnant.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
Research Team
M
Miran Cho
CONTACT
M
Mila Trabanino
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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