Extended-release Sodium Oxybate in Children

PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

July 31, 2027

Conditions
Narcolepsy Type 1 (NT 1)
Interventions
DRUG

Extended-release sodium oxybate

Participants will take Extended-release sodium Oxybate (Lumryz) 4.5-9 g oral suspension in approximately ⅓ cup of water orally once a day before bedtime. Dosage of Lumryz will be the same as the equivalent total dose of the Non-Extended-release Oxybate (Xywav or Xyrem) that participants use before starting the study

DRUG

Non-extended-release oxybates

Participants will take Non-Extended-release Oxybates (Xyrem oral solution or Xywav oral solution) 4.5-9 g orally per night (divided into two doses, once before bedtime and another dose 2-4 hours later) at the same dose of Xyrem or Xywav that participants use before starting the study will be continued to compare with Extended-release sodium Oxybate (Lumryz)

Trial Locations (1)

94063

RECRUITING

Stanford University, Redwood City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Avadel

INDUSTRY

lead

Stanford University

OTHER

NCT06809803 - Extended-release Sodium Oxybate in Children | Biotech Hunter | Biotech Hunter