Extended-release Sodium Oxybate for Narcolepsy
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial requires participants to be on a stable dose of their current medications, so you will not have to stop taking them.
Is extended-release sodium oxybate safe for humans?
Extended-release sodium oxybate is under review for treating narcolepsy, and while specific long-term safety data for this formulation is limited, sodium oxybate has been used for narcolepsy for many years. Safety concerns with immediate-release versions include dosing errors, but no specific safety issues for the extended-release version have been highlighted in the available research.12345
How is the drug extended-release sodium oxybate different from other narcolepsy treatments?
Research Team
Oliver Sum-Ping, MD
Principal Investigator
Stanford University
Eligibility Criteria
This trial is for children with narcolepsy type 1, which includes those who experience sudden muscle weakness (cataplexy). Specific eligibility details are not provided, but typically participants must meet certain health standards and not be taking conflicting medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either extended-release sodium oxybate or non-extended-release oxybates to assess treatment preferences, safety, convenience, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Extended-release Sodium Oxybate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Avadel
Industry Sponsor