A Phase 2 interventional study of Extended-release sodium oxybate and Non-extended-release oxybates in Narcolepsy Type 1 (NT 1), sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 7 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by Stanford University · Phase 2, Interventional, and Other
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.
157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.
This study's planned enrollment of 36 is below the median of 78 across 114 interventional studies indexed under Narcolepsy.
Browse Narcolepsy studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants who have any of the following conditions will not be included in the study
Participants in this arm will take extended-release sodium oxybate
Drug: Extended-release sodium oxybate · Drug: Non-extended-release oxybates
Participants in this arm will take non-extended-release sodium oxybate
Drug: Extended-release sodium oxybate · Drug: Non-extended-release oxybates
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
Also known as: Lumryz
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)
Also known as: Xywav, Xyrem
Participant preference for selecting the extended vs non-extended release oxybates
Participants will be asked at the end of the study whether participants prefer extended-release sodium oxybate vs sodium oxybate vs calcium, magnesium, potassium and sodium oxybates
Time frame: Baseline, up to 8-12 weeks through study completion
Change in Epworth Sleepiness Scales for Children and Adolescents (ESS-CHAD) score
ESS-CHAD is a multi-item questionnaire which asks the participants to rate their chances of falling asleep during various normal daily activities. 4-point Likert scale will be used. The score ranges from 0-24. A higher score means higher chance of falling asleep.
Time frame: Baseline, up to 8-12 weeks through study completion
Number of cataplexy attacks
The study team will ask the participants to report the number of cataplexy attacks as measured by Sleep and Symptoms diary when participants switch to the other intervention.
Time frame: Baseline, up to 8-12 weeks through study completion
Change in Patient Global Impression of Change (PGIc) scale score
The PGIc is a 7-point scale. Participants will be asked to rate their narcolepsy impression since the end of the Stable-Dose Period. The scale is Very much better, Much better, A little better, No change, A little worse, Much worse, and Very much worse.
Time frame: Baseline, up to 8-12 weeks through study completion
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.
Of 15 phase 2 interventional studies under Narcolepsy, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 20 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Sodium Oxybate