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NCT03533114 · ClinicalTrials.gov registry record · Phase 3
A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension
A Phase 3 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 154
- Enrollment target
NCT03533114: Completed Phase 3 study, sponsored by Jazz Pharmaceuticals.
NCT03533114 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 154 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03533114, a Phase 3 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 154 participants
- Enrollment target
Study Summary
This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
Primary Outcome
The ESS is a 8-item self reported questionnaire intended to measure daytime sleepiness. In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities. The ESS total score range is 1 to 24. Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing." Thus, the ESS scale range is as
Interventions
- DRUG JZP-258
- DRUG Placebo Oral Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2020-12-18 |
| Phase | Phase 3 |
What the finished NCT03533114 record still lists
NCT03533114 is an interventional study that assigns participants to a tested intervention. The registered 154 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 (80% lower).
The record links to 0 conditions, and to 2 interventions - of which JZP-258 is the first listed.
NCT03533114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03533114 about?
NCT03533114 is a clinical study titled "A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension". This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.
What is the current status of trial NCT03533114?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2018-11-27. Estimated completion is 2020-12-18.
What interventions are being tested in trial NCT03533114?
The interventions under investigation include: JZP-258 (DRUG), Placebo Oral Solution (DRUG).
Who is sponsoring clinical trial NCT03533114?
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 NCT03533114's enrollment target sits among peer trials
154 1509th of 2000 higher than 491 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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