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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: Completed Phase 3 study, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment-emergent adverse events (TEAE) were defined as any AEs that based on start date information occurs after the first intake of study treatment.
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 |
What the finished NCT02823145 record still lists
NCT02823145 is an interventional study that assigns participants to a tested intervention. The registered 375 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 (51% lower).
The record links to 0 conditions, and to 1 intervention - of which ZX008 (Fenfluramine Hydrochloride) is the first listed.
NCT02823145 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02823145's enrollment target sits among peer trials
375 988th of 2000 higher than 1,010 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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