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COMPLETED Phase 3

A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

NCT03936777 · View on ClinicalTrials.gov ↗

Study Summary

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

Interventions

  • DRUG ZX008 (Fenfluramine Hydrochloride)

Study Locations (20)

Florida

  • Ep0215 115 — Gulf Breeze
  • Ep0215 104 — Miami
  • Ep0215 141 — Orlando
  • Ep0215 121 — Winter Park

California

  • Ep0215 144 — Los Angeles
  • Ep0215 108 — San Diego
  • Ep0215 101 — San Francisco

Minnesota

  • Ep0215 109 — Rochester
  • Ep0215 132 — Roseville

New Jersey

  • Ep0215 105 — Hackensack
  • Ep0215 118 — Livingston

New York

  • Ep0215 150 — Hawthorne
  • Ep0215 142 — New York

Arizona

  • Ep0215 107 — Tucson

Colorado

  • Ep0215 103 — Aurora

Georgia

  • Ep0215 117 — Atlanta

Trial Details

FieldValue
Enrollment Target 412 participants
Start Date 2019-04-22
Est. Completion 2025-05-08
Phase Phase 3

Sponsor

Zogenix

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03936777

The ClinicalTrials.gov registry entry for NCT03936777 describes a study currently listed as completed. It is categorized as Phase 3, 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 412 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Dravet Syndrome appearing as the primary indexed condition, and to 1 intervention — of which ZX008 (Fenfluramine Hydrochloride) 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: NCT03936777 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Minnesota. 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 NCT03936777 about?

NCT03936777 is a clinical study titled "A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome". This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy

What is the current status of trial NCT03936777?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 412 participants. The study started on 2019-04-22. Estimated completion is 2025-05-08.

What conditions does trial NCT03936777 study?

This clinical trial studies the following conditions: Dravet Syndrome, Lennox Gastaut Syndrome, Epileptic Encephalopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03936777?

The interventions under investigation include: ZX008 (Fenfluramine Hydrochloride) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03936777?

This trial is sponsored by Zogenix, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03936777 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. 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