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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Stanford University
RECRUITING
Redwood City
Contact Information
Primary
Miran Cho
mirancho@stanford.edu
650-724-4149
Backup
Mila Trabanino
milaludi@stanford.edu
Time Frame
Start Date: 2025-07
Estimated Completion Date: 2027-07
Participants
Target number of participants: 36
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: Avadel

This content was sourced from clinicaltrials.gov

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