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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02823145

Public ClinicalTrials.gov record NCT02823145. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 6:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.

Study identification

NCT ID
NCT02823145
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
375 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 35 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 8, 2016 (Actual)
Primary completion
Jan 27, 2023 (Actual)
Completion
Jan 27, 2023 (Actual)
Last update posted
Jul 14, 2025

2016 – 2023

United States locations

U.S. sites
24
U.S. states
16
U.S. cities
23
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016 —
Center for Neurosciences - Tucson Tucson Arizona 85718 —
Children's Hospital of Orange County Orange California 92868 —
Rady Children's Hospital San Diego San Diego California 92123 —
University of California San Francisco San Francisco California 94158 —
The Children's Hospital Colorado Aurora Colorado 80045 —
NW FL Clinical Research Group, LLC Gulf Breeze Florida 32561 —
Miami Children's Hospital Brain Institute Miami Florida 33155 —
Neurology and Epilepsy Research Center Orlando Florida 32819 —
Clinical Integrative Research Center of Atlanta, Panda Neurology Atlanta Georgia 30328 —
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Boston Children's Hospital Boston Massachusetts 02115 —
Children's Hospital Of Michigan Detroit Michigan 48201 —
Mayo Clinic Rochester Minnesota 55905 —
Minnesota Epilepsy Group, P.A. Saint Paul Minnesota 55102 —
Institute of Neurology and Neurosurgery at St. Barnabus Livingston New Jersey 07039 —
University Hospitals Cleveland Medical Center Cleveland Ohio 44103 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
Le Bonheur Children's Hospital Memphis Tennessee 38103 —
Cook Children's Medical Center Fort Worth Texas 76104 —
University of Utah Salt Lake City Utah 84113 —
Seattle Children's Hospital Seattle Washington 98105 —
MultiCare Institute for Research & Innovation Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 43 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02823145, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 14, 2025 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02823145 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →