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
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.
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
Study identification
- NCT ID
- NCT02823145
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Industry
- Enrollment
- 375 participants
Conditions and interventions
Conditions
Interventions
- ZX008 (Fenfluramine Hydrochloride) 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
- Jun 7, 2016
- Primary completion
- Jan 26, 2023
- Completion
- Jan 26, 2023
- Last update posted
- Jul 13, 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 13, 2025 · Synced May 20, 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 NCT02823145 live on ClinicalTrials.gov.