Extended‑release sodium oxybate for children with narcolepsy type 1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.