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Recruiting NCT06809803

Extended-release Sodium Oxybate in Children

Phase II Interventional Narcolepsy Type 1 (NT 1)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Extended-release sodium oxybate, Non-extended-release oxybates.
Who it may be relevant to
Registry conditions: Narcolepsy Type 1 (NT 1). Basic parameters: 7 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Drug Extended-release sodium oxybate
    Participants will take Extended-release sodium Oxybate (Lumryz) 4.5-9 g oral suspension in approximately ⅓ cup of water orally once a day before bedtime. Dosage of Lumryz will be the same as the equivalent total dose of the Non-Extended-release Oxybate (Xywav or Xyrem) that participants use before starting the study
  • Drug Non-extended-release oxybates
    Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and another dose 2-4 hours later) at the same dose of Xyrem or Xywav that participants use before starting the study will be continued to compare with Extended-release sodium Oxybate (Lumryz)

Primary outcome measures

  • Participant preference for selecting the extended vs non-extended release oxybates [Time frame: Baseline, up to 8-12 weeks through study completion]
Secondary outcome measures (3)
  • Change in Epworth Sleepiness Scales for Children and Adolescents (ESS-CHAD) score [Time frame: Baseline, up to 8-12 weeks through study completion]
  • Number of cataplexy attacks [Time frame: Baseline, up to 8-12 weeks through study completion]
  • Change in Patient Global Impression of Change (PGIc) scale score [Time frame: Baseline, up to 8-12 weeks through study completion]

Eligibility criteria

Inclusion criteria

  • Participants must be under the care of a doctor at the Stanford Sleep Clinic.
  • 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.
  • Parent(s), or guardian(s) have signed a consent form and the child must agree to participate.
  • 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

  • Uncontrolled mental health problems
  • Uncontrolled sleep problems that lead to sleepiness.
  • Currently having thought about ending one's life or sadness or loss of interest
  • Currently having a problem with illegal drug use
  • Currently pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Stanford University — Redwood City

Identifiers

NCT: NCT06809803 · 75896

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗