Extended-release Sodium Oxybate in Children

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT06809803
Phase
PHASE2
Status
Recruiting
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Conditions

  • Narcolepsy Type 1 (NT 1)

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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)

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityRedwood CityCalifornia94063
Miran Cho
[email protected]
650-724-4149
Mila Trabanino
[email protected]

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By research site
Stanford University· Redwood City, CA