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
Completed · Phase 3
Conditions studied: Dravet Syndrome
In brief
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
Key facts
- Study ID
- NCT02823145
- Run by
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- People needed
- 375
- Starts
- 2016-06-08
- Expected to finish
- 2023-01-27
- Last updated by the study team
- 2025-07-14
Who can join
Age: 2 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Center for Neurosciences - Tucson — Tucson, Arizona, United States
- Children's Hospital of Orange County — Orange, California, United States
- Rady Children's Hospital San Diego — San Diego, California, United States
- University of California San Francisco — San Francisco, California, United States
- The Children's Hospital Colorado — Aurora, Colorado, United States
- NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States
- Miami Children's Hospital Brain Institute — Miami, Florida, United States
- Neurology and Epilepsy Research Center — Orlando, Florida, United States
- Clinical Integrative Research Center of Atlanta, Panda Neurology — Atlanta, Georgia, United States
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Children's Hospital Of Michigan — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Minnesota Epilepsy Group, P.A. — Saint Paul, Minnesota, United States
- Institute of Neurology and Neurosurgery at St. Barnabus — Livingston, New Jersey, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Le Bonheur Children's Hospital — Memphis, Tennessee, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- MultiCare Institute for Research & Innovation — Tacoma, Washington, United States
- Melbourne Brain Centre Austin Hospital — Heidelberg, Australia
- Phoenix Children's Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.