Extended-release Sodium Oxybate for Narcolepsy

Recruiting in Palo Alto (17 mi)

Overseen byOliver Sum-Ping, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Prior Safety Data

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.

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

Participants must be under the care of a doctor at the Stanford Sleep Clinic

I have narcolepsy type 1, confirmed by tests or symptoms.

Parent(s), or guardian(s) have signed a consent form and the child must agree to participate

+1 more

Exclusion Criteria

I have sleep problems that make me very sleepy.

Participants who are currently pregnant

Participants who have uncontrolled mental health problems

+2 more

Participant Groups

The study compares children's preferences between traditional sodium oxybate treatments and a new extended-release version. It also evaluates the safety, convenience, and effectiveness of the extended-release medication in treating narcolepsy type 1.

2Treatment groups

Experimental Treatment

Active Control

Group I: Extended-release sodium oxybateExperimental Treatment2 Interventions

Participants in this arm will take extended-release sodium oxybate

Group II: Non-extended-release oxybatesActive Control2 Interventions

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