NCT07625280Phase 3Recruiting

A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2027-12-23Estimated

Enrollment · participants120Estimated

Source updated2026-08-19Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-19 · 2 fields changed

Planned enrollment increased by 12 participants

− Before

~~108 participants (planned)~~

+ After

120 participants (planned)

Recruitment status changed

− Before

~~Not yet recruiting~~

+ After

Recruiting

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Study details

Conditions studied

Narcolepsy; Idiopathic Hypersomnia

Treatments or interventions studied

XywavDrugAlso known as JZP258

Primary outcomes · main study measures

Read the study measures

measure: Change in Epworth Sleepiness Scale (ESS) scores; description: ESS is a self-administered questionnaire with 8 questions. Each question is scored on a scale ranging from 0 (would never fall asleep) to 3 (high chance of falling asleep). It has a total score ranging from 0 to 24, with a higher score representing increased daytime sleepiness.; timeFrame: End of Stable Dose Period (up to Week 14), up to end of Double-Blind Randomized-Withdrawal Period (up to Week 16)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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