Recruiting
Phase 2

Extended-release Sodium Oxybate

Sponsor:

Stanford University

Code:

NCT06809803

Conditions

Narcolepsy Type 1 (NT 1)

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Extended-release sodium oxybate

Non-extended-release oxybates

Study Details

Brief summary:

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)

Study ID

NCT06809803

Start date

Oct 27, 2025

Status verified date

Nov, 2025

Completion date

Jul, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Extended-release sodium oxybate

Participants in this arm will take extended-release sodium oxybate

active comparator: Non-extended-release oxybates

Participants in this arm will take non-extended-release sodium oxybate

Interventions

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

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 measure

  • Participant preference for selecting the extended vs non-extended release oxybates [ Time Frame: Baseline, up to 8-12 weeks through study completion ]

Central Contacts and Locations

Central contacts

Miran Cho

650-724-4149mirancho@stanford.edu

Mila Trabanino

milaludi@stanford.edu

Locations

Stanford University

Recruiting

Redwood City, California, United States, 94063

Contacts

Miran Cho

650-724-4149mirancho@stanford.edu

Mila Trabanino

milaludi@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Nov 6, 2025

Last verified

Nov, 2025

Keywords

  • Narcolepsy
  • Children
  • Sodium oxybate
  • treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-11-06.