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

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. According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

Number of adverse events including serious adverse events, number of adverse events leading to study withdrawal

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
Zogenix International Limited, Inc., a subsidiary of Zogenix

6 total trials

What the finished NCT03467113 record still lists

NCT03467113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 109-participant average among 12 other Dravet Syndrome trials with a reported enrollment target (92% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Dravet Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03467113's enrollment target sits among peer trials

9 12th of 12 higher than 1 of 12 other Dravet Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Dravet Syndrome 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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Related registry views

Source: ClinicalTrials.gov NCT03467113, the US trial registry maintained by the National Library of Medicine. NCT03467113 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.