A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
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.
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
Study identification
- NCT ID
- NCT03355209
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Industry
- Enrollment
- 296 participants
Conditions and interventions
Conditions
Interventions
- ZX008 0.2 or 0.8 mg/kg/day Drug
- Matching Placebo Drug
Drug
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 26, 2017
- Primary completion
- May 22, 2024
- Completion
- May 22, 2024
- Last update posted
- Jul 2, 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 2, 2025 · Synced Jul 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03355209 live on ClinicalTrials.gov.