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Extended-release Sodium Oxybate in Children

Extended-release Sodium Oxybate in Children

Recruiting
7-17 years
All
Phase 2

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Overview

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

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

Study details
    Narcolepsy Type 1 (NT 1)

NCT06809803

Stanford University

5 July 2025

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