Extended-release Sodium Oxybate in Children
ConditionNarcolepsy Type 1 (NT 1)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-17
SponsorStanford University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Extended-release sodium oxybate
- Non-extended-release oxybates
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
Avadel
Collaborator
Source ClinicalTrials.gov