RECRUITING

Extended-release Sodium Oxybate in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety, Convenience, and Tolerability of a Nightly Single Oral Dose of Extended-release Sodium Oxybate in Children

Quick Facts

Study Start:2025-07
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06809803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must be under the care of a doctor at the Stanford Sleep Clinic.
  2. 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. 3. Parent(s), or guardian(s) have signed a consent form and the child must agree to participate.
  4. 4. Participants are on a stable dose of medications
  1. 1. Uncontrolled mental health problems
  2. 2. Uncontrolled sleep problems that lead to sleepiness.
  3. 3. Currently having thought about ending one's life or sadness or loss of interest
  4. 4. Currently having a problem with illegal drug use
  5. 5. Currently pregnant

Contacts and Locations

Study Contact

Miran Cho
CONTACT
650-724-4149
mirancho@stanford.edu
Mila Trabanino
CONTACT
milaludi@stanford.edu

Principal Investigator

Oliver Sum-Ping, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University
Redwood City, California, 94063
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Oliver Sum-Ping, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Narcolepsy
  • Children
  • Sodium oxybate
  • treatment

Additional Relevant MeSH Terms

  • Narcolepsy Type 1 (NT 1)