A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
← catalyst calendarNCT07625280 · readout in 490 d
Sponsored by Jazz Pharmaceuticals (industry) · JAZZ — their whole pipeline →. With Jazz Pharmaceuticals Ireland Limited.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
120estimated
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-07-09 | actual | When the study began enrolling |
| Primary completion | 2027-12-23 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-01-06 | estimated | The whole study's end, after follow-up |
| First posted | 2026-06-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Narcolepsy
- Idiopathic Hypersomnia
Interventions
- Drug: Xywav — also filed as JZP258
- Other: Placebo
Primary outcome
what the primary-completion date above is the date OFChange in Epworth Sleepiness Scale (ESS) scores
measured End of Stable Dose Period (up to Week 14), up to end of Double-Blind Randomized-Withdrawal Period (up to Week 16)
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