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NCT02823145 · ClinicalTrials.gov registry record · Phase 3
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
A Phase 3 study, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 375
- Enrollment target
NCT02823145 is a Phase 3 study that has completed, run by Zogenix International Limited, Inc., a subsidiary of Zogenix. The registered enrollment target is 375 participants.
The verdict
NCT02823145, a Phase 3 study, has completed, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 375 participants
- Enrollment target
Study Summary
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
Interventions
- DRUG ZX008 (Fenfluramine Hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 375 participants |
| Start Date | 2016-06-08 |
| Est. Completion | 2023-01-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02823145
The ClinicalTrials.gov registry entry for NCT02823145 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ZX008 (Fenfluramine Hydrochloride) is the first listed.
NCT02823145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02823145 about?
NCT02823145 is a clinical study titled "An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome". This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
What is the current status of trial NCT02823145?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 375 participants. The study started on 2016-06-08. Estimated completion is 2023-01-27.
What interventions are being tested in trial NCT02823145?
The interventions under investigation include: ZX008 (Fenfluramine Hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT02823145?
This trial is sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 6 total clinical trials registered on ClinicalTrials.gov.
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