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NCT Number: NCT06809803

Extended-release Sodium Oxybate in Children

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.

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Key information

Conditions

Narcolepsy Type 1 (NT 1) Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended-release sodium oxybate

Drug

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

Other names: Lumryz

Non-extended-release oxybates

Drug

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)

Other names: Xywav, Xyrem

Primary outcomes

  1. Participant preference for selecting the extended vs non-extended release oxybates

    Time frame: Baseline, up to 8-12 weeks through study completion

    Participants will be asked at the end of the study whether participants prefer extended-release sodium oxybate vs sodium oxybate vs calcium, magnesium, potassium and sodium oxybates

Secondary outcomes

  1. Change in Epworth Sleepiness Scales for Children and Adolescents (ESS-CHAD) score

    Time frame: Baseline, up to 8-12 weeks through study completion

    ESS-CHAD is a multi-item questionnaire which asks the participants to rate their chances of falling asleep during various normal daily activities. 4-point Likert scale will be used. The score ranges from 0-24. A higher score means higher chance of falling asleep.

  2. Number of cataplexy attacks

    Time frame: Baseline, up to 8-12 weeks through study completion

    The study team will ask the participants to report the number of cataplexy attacks as measured by Sleep and Symptoms diary when participants switch to the other intervention.

  3. Change in Patient Global Impression of Change (PGIc) scale score

    Time frame: Baseline, up to 8-12 weeks through study completion

    The PGIc is a 7-point scale. Participants will be asked to rate their narcolepsy impression since the end of the Stable-Dose Period. The scale is Very much better, Much better, A little better, No change, A little worse, Much worse, and Very much worse.

Study contacts

Contact information is provided by the study sponsor or research team.

Mila Trabanino

CONTACT

[email protected]

Miran Cho

CONTACT

[email protected]

650-724-4149

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Avadel

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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