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COMPLETED 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

NCT03467113 · View on ClinicalTrials.gov ↗

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).

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03467113

The ClinicalTrials.gov registry entry for NCT03467113 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 9 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 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03467113 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Georgia, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03467113?

This trial is sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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