Extended-release Sodium Oxybate in Children
Recruiting
Phase 2
Interventional Study
Narcolepsy Type 1 (NT 1)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 7 – 17
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 36 (estimated)
- Sponsor
- Stanford University · Other
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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. …
Trial Locations
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Eligibility Criteria
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 …
Contacts