Extended-release Sodium Oxybate in Children

Stanford University

Status and phase: Enrolling; Phase 2

Conditions: Narcolepsy Type 1 (NT 1)

Treatments: Drug: Non-extended-release oxybates; Drug: Extended-release sodium oxybate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06809803

75896

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Extended-release sodium oxybate

Experimental group

Description:

Participants in this arm will take extended-release sodium oxybate

Treatment:

Drug: Extended-release sodium oxybate

Drug: Non-extended-release oxybates

Non-extended-release oxybates

Active Comparator group

Description:

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

Treatment:

Drug: Extended-release sodium oxybate

Drug: Non-extended-release oxybates