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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.

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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

FieldValue
Enrollment Target 375 participants
Start Date 2016-06-08
Est. Completion 2023-01-27
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.