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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 is a Phase 3 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 154 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03533114
The ClinicalTrials.gov registry entry for NCT03533114 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which JZP-258 is the first listed.
NCT03533114 reports 0 study locations.
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.
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