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NCT03467113 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol

A Phase 1 study of Dravet Syndrome and Lennox Gastaut Syndrome, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.

Completed
Registry status
Phase 1
Development phase
9
Enrollment target
2
Study locations

NCT03467113 is a Phase 1 study of Dravet Syndrome and Lennox Gastaut Syndrome that has completed, run by Zogenix International Limited, Inc., a subsidiary of Zogenix. The registered enrollment target is 9 participants, below the 109-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03467113, a Phase 1 study of Dravet Syndrome and Lennox Gastaut Syndrome, has completed, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.

COMPLETED
Registry status
Phase 1
Development phase
9 participants
Enrollment target
2
Study locations

Study Summary

This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).

Conditions Studied

Dravet Syndrome Lennox Gastaut Syndrome

Interventions

  • DRUG Cannabidiol
  • DRUG ZX008 0.2 to 0.8 mg/kg/day

Study Locations (2)

Georgia

  • PANDA Neurology/CIRCA - Atlanta

Washington

  • MultiCare Institute for Research & Innovation - Tacoma

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2018-01-19
Est. Completion 2020-06-24
Phase Phase 1

Sponsor

Zogenix International Limited, Inc., a subsidiary of Zogenix

6 total trials

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What the Registry Record Tells You About NCT03467113

The ClinicalTrials.gov registry entry for NCT03467113 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (92% lower). 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 2 conditions, with Dravet Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Cannabidiol is the first listed.

NCT03467113 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Georgia, Washington.

Frequently Asked Questions

What is clinical trial NCT03467113 about?

NCT03467113 is a clinical study titled "A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol". This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).

What is the current status of trial NCT03467113?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2018-01-19. Estimated completion is 2020-06-24.

What conditions does trial NCT03467113 study?

This clinical trial studies the following conditions: Dravet Syndrome, Lennox Gastaut Syndrome.

What interventions are being tested in trial NCT03467113?

The interventions under investigation include: Cannabidiol (DRUG), ZX008 0.2 to 0.8 mg/kg/day (DRUG).

Who is sponsoring clinical trial NCT03467113?

This trial is sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03467113 being conducted?

This trial has 2 study locations across Georgia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.