NCT06809803 Extended-release Sodium Oxybate in Children
| NCT ID | NCT06809803 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stanford University |
| Condition | Narcolepsy Type 1 (NT 1) |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2025-10-27 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Oliver Sum-Ping, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06809803 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Narcolepsy Type 1 (NT 1). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06809803 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06809803 currently recruiting?
Yes, NCT06809803 is actively recruiting participants. Contact the research team at mirancho@stanford.edu for enrollment information.
Where is the NCT06809803 trial being conducted?
This trial is being conducted at Redwood City, United States.
Who is sponsoring the NCT06809803 clinical trial?
NCT06809803 is sponsored by Stanford University. The principal investigator is Oliver Sum-Ping, MD at Stanford University. The trial plans to enroll 36 participants.