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

PHASE3CompletedINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

June 8, 2016

Primary Completion Date

January 27, 2023

Study Completion Date

January 27, 2023

Conditions
Dravet Syndrome
Interventions
DRUG

ZX008 (Fenfluramine Hydrochloride)

Trial Locations (67)

19104

Children's Hospital of Philadelphia, Philadelphia

30328

Clinical Integrative Research Center of Atlanta, Panda Neurology, Atlanta

32561

NW FL Clinical Research Group, LLC, Gulf Breeze

32819

Neurology and Epilepsy Research Center, Orlando

33155

Miami Children's Hospital Brain Institute, Miami

38103

Le Bonheur Children's Hospital, Memphis

44103

University Hospitals Cleveland Medical Center, Cleveland

48201

Children's Hospital Of Michigan, Detroit

55102

Minnesota Epilepsy Group, P.A., Saint Paul

55905

Mayo Clinic, Rochester

60611

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago

76104

Cook Children's Medical Center, Fort Worth

80045

The Children's Hospital Colorado, Aurora

84113

University of Utah, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

85718

Center for Neurosciences - Tucson, Tucson

92123

Rady Children's Hospital San Diego, San Diego

92868

Children's Hospital of Orange County, Orange

94158

University of California San Francisco, San Francisco

98105

Seattle Children's Hospital, Seattle

98405

MultiCare Institute for Research & Innovation, Tacoma

02114

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital, Boston

07039

Institute of Neurology and Neurosurgery at St. Barnabus, Livingston

Unknown

Melbourne Brain Centre Austin Hospital, Heidelberg

Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital, South Brisbane

The Children's Hospital Westmead Dept. of Neurology and Neurosurgery, Westmead

Universitair Ziekenhuis Antwerpen, Edegem

Centre Hospitalier Universitaire Sainte-Justine, Montreal

British Columbia Children's Hospital, Vancouver

Danish National Epilepsy Centre, Dianalund

CHU Amiens-Picardie Service De Neurologie Pediatrique, Amiens

CHU De Bordeaux Service De Pédiatrie Médicale, Bordeaux

CHRU Lille Antenne Pédiatrique Du CIC - Hôpital Jeanne De Flandre, Lille

HOPITAL DEL LA TIMONE - HOPITAL HENRI GASTAUT Hôpital De La Timone Neurologie Pédiatrique Pneumologie Pédiatrique Et Médecine Infantile, Marseille

Hôpital Robert Debré Pôle: Pédiatrie Médicale Service: Neurologie Et Maladies Métaboliques, Paris

Hôpital Universitaire Necker-Enfants Malades Service de neurologie pédiatrique Centre de référence épilepsies rares (CReER), Paris

DRK Kliniken Berlin - Westend Epilepsiezentrum / Neuropaediatrie, Berlin

Krankenhaus Mara Epilepsie-Zentrum Bethel, Bielefeld

Universitaetsklinikum Freiburg Zentrum fuer Kinder- und Jugendmedizin, Freiburg im Breisgau

Universitaetsklinikum Jena Klinik fuer Kinder- und Jugendmedizin Neuropaediatrie, Jena

Universitaetsklinikum Schleswig-Holstein Campus Kiel Klinik fuer Neuropaediatrie, Kiel

Kleinwachau Saechsisches Epilepsiezentrum Radeberg gemeinnuetzige GmbH, Radeberg

Universitaetsklinik fuer Kinder- und Jugendmedizin Abteilung III, Tübingen

Schoen Klinik Vogtareuth Neuropaediatrie und Neurologische Rehabilitation, Epilepsiezentrum fuer Kinder und Jugendlische, Tagesklinik fuer Neuropaediatrie, Vogtareuth

AOU Anna Meyer Clinica di Neurologia Pediatrica, Florence

Istituto Pediatrico Giannina Gaslini Dipartimento di Neurologia, Genova

A.O. Carlo Poma, Mantova

Istituto Neurologica Carlo Besta, Milan

Ospedale Fatebenefratelli e Oftalmico, Milan

Policlinico A. Gemelli, Roma

U.O. Neurologia Dipartimento di Neuroscienze Ospedale Pediatrico Bambino Gesù, Roma

Ospedale Civile Maggiore di Borgo Trento - Ospedale della Donna e del Bambino, Verona

Saitama Children's Medical Center, Saitama

National Epilepsy Center Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka

Tokyo Women's Medical University Hospital, Tokyo

Kempenhaeghe, Heeze

Stichting Epilepsie Instellingen Nederland, Zwolle

Hospital Sant Joan de Déu, Barcelona

Hospital Ruber Internacional Primera Planta Servicio de Neurologia, Madrid

Clinica Universitaria de Navarra Fase 4. Segunda planta, Consulta de Pediatria, Pamplona

Birmingham Children Hospital NHS Foundation Trust, Birmingham

Institute of Neurosciences Queen Elizabeth University Hospital, Glasgow

Alder Hey Hospital, Liverpool

Great Ormond Street Hospital for Children NHS Foundation Trust, London

St. Thomas Hospital, London

Sheffield Children's Hospital, Sheffield

All Listed Sponsors
lead

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

INDUSTRY

NCT02823145 - 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 | Biotech Hunter | Biotech Hunter