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NCT07625280 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Not yet
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
NCT07625280: Clinical Trial Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT07625280 is a Phase 3 study that has not yet begun recruiting, run by Jazz Pharmaceuticals. The registered enrollment target is 108 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07625280, a Phase 3 study, has not yet begun recruiting, sponsored by Jazz Pharmaceuticals.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG Xywav
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2028-01-06 |
| Phase | Phase 3 |
What is known before NCT07625280 opens enrollment
NCT07625280 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07625280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07625280 about?
NCT07625280 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH". The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).
What is the current status of trial NCT07625280?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2026-06-30. Estimated completion is 2028-01-06.
What interventions are being tested in trial NCT07625280?
The interventions under investigation include: Placebo (OTHER), Xywav (DRUG).
Who is sponsoring clinical trial NCT07625280?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07625280's enrollment target sits among peer trials
108 1664th of 2000 higher than 335 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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