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Extended-release Sodium Oxybate in Children

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.

Conditions

Narcolepsy Type 1 (NT 1)
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Related Conditions:

Narcolepsy Type 1 (NT 1)

Study Overview

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Study Details

Study 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.

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

Extended-release Sodium Oxybate in Children

Condition
Narcolepsy Type 1 (NT 1)
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford University, Redwood City, California, United States, 94063

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

7 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Oliver Sum-Ping, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

2027-07