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New treatment option for Narcolepsy Type 1 (NT 1)
Official title Extended-release Sodium Oxybate in Children
ClinicalTrials.gov ID: NCT06809803
What this study is testing
What is Extended-release sodium oxybate?
Extended-release sodium oxybate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for narcolepsy type 1 (nt 1).
Also referred to as Lumryz.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 7 to 17
You may be able to join if
- 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...
- 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
You likely can't join if
- Participants who have any of the following conditions will not be included in the study
- 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
- Currently pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Redwood City, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 7 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Redwood City, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.