Extended‑release sodium oxybate for children with narcolepsy type 1
Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children
This will test whether an extended‑release form of sodium oxybate is safer, more convenient, and preferred by children with narcolepsy type 1 compared with non‑extended‑release oxybate options.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Redwood City, California) |
| Trial ID | NCT06809803 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional trial enrolls children with documented narcolepsy type 1 who are followed at the Stanford Sleep Clinic to compare extended‑release sodium oxybate with non‑extended‑release oxybates. Participants will receive the two treatment approaches and researchers will collect data on patient and parent treatment preference, safety, tolerability, convenience, and symptom response. The trial requires informed parental/guardian consent and stable background medications during participation. Safety monitoring and standardized measures of narcolepsy symptoms and tolerability will be used to compare outcomes between the formulations.
Who should consider this trial
Good fit: Children with a documented diagnosis of narcolepsy type 1 who are under the care of the Stanford Sleep Clinic, are on stable medications, and whose parent/guardian provides consent and the child agrees to participate.
Not a fit: Patients with uncontrolled mental health or sleep disorders causing sleepiness, current suicidal thoughts or severe depression, active illegal drug use, or current pregnancy are excluded and unlikely to benefit from joining this trial.
Why it matters
Potential benefit: If successful, the extended‑release option could offer children a more convenient and better tolerated oxybate choice that works as well as current formulations.
How similar studies have performed: Immediate‑release sodium oxybate is an established treatment for narcolepsy and extended‑release formulations have shown positive results in adults, but pediatric data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Redwood City, California
- Stanford University — Redwood City, California, United States (Recruiting)
Study contacts
- Principal investigator: Oliver Sum-Ping, MD — Stanford University
- Study coordinator: Miran Cho
- Email: mirancho@stanford.edu
- Phone: 650-724-4149
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.