Actively Recruiting
Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children with Narcolepsy Type 1
Led by Stanford University · Updated on 2025-11-06
36
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
A
Avadel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatment preferences and effects of Extended-release sodium oxybate compared to Non-extended-release oxybates in children with narcolepsy type 1. This Phase 2 study aims to assess the safety, convenience, tolerability, and effectiveness of Extended-release sodium oxybate for managing this condition. The study is sponsored by Stanford University and focuses on children aged 7 to 17 years with a confirmed diagnosis of narcolepsy type 1. Participants are randomly assigned to one of two groups: one will take Extended-release sodium oxybate (Lumryz), a once-nightly oral suspension taken before bedtime, while the other group will continue with Non-extended-release oxybates (Xyrem or Xywav), taken in two divided doses per night. Dosing for both treatments is matched based on the participant's current medication use before the study. The study treatment period lasts 8 to 12 weeks. Throughout the study, participants will have their preferences monitored between the two oxybate formulations. Researchers will also track changes in daytime sleepiness using the Epworth Sleepiness Scale for Children and Adolescents, the number of cataplexy attacks, and overall patient impression of change. Safety and tolerability will be observed during this period. The study concludes by assessing which treatment children prefer and how well they tolerate the medications.
CONDITIONS
Brief 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
- Documented diagnosis of narcolepsy type 1 confirmed by sleepiness and specific tests or history
- Parent(s) or guardian(s) have signed consent and child agrees to participate
- Participants are on a stable dose of medications
You will not qualify if you...
- Uncontrolled mental health problems
- Uncontrolled sleep problems causing sleepiness
- Currently experiencing thoughts of ending life, sadness, or loss of interest
- Current problem with illegal drug use
- Currently pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 to 12 weeks through study completion
Participants take either extended-release sodium oxybate once nightly or non-extended-release oxybates in two doses nightly in a crossover design to compare safety, convenience, and tolerability.
Trial Site Locations
Total: 1 location
1
Stanford University
Redwood City, California, United States, 94063
Actively Recruiting
Research Team
M
Miran Cho
M
Mila Trabanino
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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