drugset / Trial / NCT06809803

Extended-release Sodium Oxybate in Children

NCT06809803

Phase 2 Recruiting 36 enrolled Stanford University Avadel · collab
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2025-10-27
Primary completion
2027-06
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Oxybate Unknown 4.5 g Oral
Subject Sodium Oxybate Unknown 9 g Oral

Indications