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Completed Phase 3 Interventional Results available

A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

ClinicalTrials.gov ID: NCT03355209

Public ClinicalTrials.gov record NCT03355209. 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 22, 2026, 9:28 PM EDT

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

Official title

A Two-Part Study of ZX008 in Children and Adults With Lennox-Gastaut Syndrome (LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapy for Seizures in Children and Adults With LGS, Followed by Part 2: An Open-label Extension to Assess Long-Term Safety of ZX008 in Children and Adults With LGS

Brief summary

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

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

Study identification

NCT ID
NCT03355209
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
296 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
Nov 27, 2017 (Actual)
Primary completion
May 23, 2024 (Actual)
Completion
May 23, 2024 (Actual)
Last update posted
Jul 3, 2025

2017 – 2024

United States locations

U.S. sites
30
U.S. states
19
U.S. cities
29
Facility City State ZIP Site status
Ep0214 107 Tucson Arizona 85718 —
Ep0214 144 Los Angeles California 90095-1752 —
Ep0214 101 San Francisco California 94158 —
Ep0214 103 Aurora Colorado 80045 —
Ep0214 149 Washington D.C. District of Columbia 20010 —
Ep0214 115 Gulf Breeze Florida 32561 —
Ep0214 104 Miami Florida 33155 —
Ep0214 141 Orlando Florida 32803 —
Ep0214 121 Orlando Florida 32819 —
Ep0214 117 Atlanta Georgia 30328 —
Ep0214 110 Chicago Illinois 60611 —
Ep0214 140 Bethesda Maryland 20817 —
Ep0214 112 Boston Massachusetts 02114 —
Ep0214 136 Grand Rapids Michigan 49503 —
Ep0214 147 Royal Oak Michigan 48073 —
Ep0214 109 Rochester Minnesota 55905 —
Ep0214 132 Saint Paul Minnesota 55102 —
Ep0214 105 Hackensack New Jersey 07601 —
Ep0214 118 Livingston New Jersey 07039 —
Ep0214 150 Hartsdale New York 10530 —
Ep0214 142 New York New York 10016 —
Ep0214 131 Cleveland Ohio 44106 —
Ep0214 143 Portland Oregon 97239 —
Ep0214 120 Philadelphia Pennsylvania 19104-4318 —
Ep0214 139 York Pennsylvania 17403 —
Ep0214 146 Dallas Texas 75235 —
Ep0214 126 Fort Worth Texas 76104 —
Ep0214 145 San Antonio Texas 78207-3108 —
Ep0214 106 Salt Lake City Utah 84113 —
Ep0214 125 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 42 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03355209, 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 3, 2025 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03355209 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →