A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

262

Participants

Timeline

Start Date

January 15, 2016

Primary Completion Date

July 29, 2020

Study Completion Date

July 29, 2020

Conditions
Dravet SyndromeSeizure Disorder
Interventions
DRUG

ZX008 (Fenfluramine Hydrochloride)

ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5. The product is sugar free and is intended to be compatible with a ketogenic diet.

DRUG

Matching Placebo

Placebo solution for ZX008. The product is sugar free and is intended to be compatible with a ketogenic diet.

Trial Locations (55)

19104

Children's Hospital of Philadelphia, Philadelphia

20133

Instituto Neurologica Carlo Besta, Milan

30328

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

37134

Ospedal Policlinico Giambattista Rossi diBorga Roma, Verona

46100

A.O Carlo Poma, Mantova

50139

AOU Anna Meyer, Florence

55905

Mayo Clinic, Rochester

60611

Children's Hospital of Chicago, Chicago

76087

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, Phoenix

85718

Center for Neurosciences - Tucson, Tucson

92123

Rady Children's Hospital San Diego, San Diego

94143

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

02467

Boston Children's Hospital, Boston

07039

Saint Barnabas Medical Center, Livingston

Unknown

Melbourne Brain Centre Austin Hospital, Melbourne

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, Antwerp

Danish National Epilepsy Centre, Dianalund

French Ref centre Necker Hospital Paris, Paris

Epilepsiezentrum / Neuropädiatrie Hedwig-von-Rittberg-Zentrum Für Kinder und Jugendliche, Berlin

Krankenhaus Mara Epilepsie-Zentrum Bethel, Bielefeld

Epilepsiezentrum Freiburg, Freiburg im Breisgau

Universitaetsklinikum Jena Klinik fuer Kinder- und Jugendmedizin Neuropaediatrie, Jena

Klinik für Neuropädiatrie Universitätsklinikum Schleswig Holstein Campus Kiel, Kiel

Kleinwachau Saechsisches Epilepsiezentrum Radeberggemeinnuetzige 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

Istituto Pediatrico Giannina Gaslini Dipartimento di Neurologia, Genova

Ospedale Fatebenefratelli e Oftalmico, Milan

Okayama University Hospital, Okayama

Saitama Children's Medical Center, Saitama-shi

National Epilepsy Center Shizuoka Institute, Shizuoka

Tokyo Women's Medical University Hospital, Shinjuku-ku

Hospital Sant Joande 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, Birmingham

Institute of Neurosciences Queens Elizabeth University Hospital, Glasgow

Alder Hey Hospital, Liverpool

Evelina Hospital, London

Great Ormonnd Street Hospital for Children NHS Foundation Trust, London

Sheffield Children's Hospital, Sheffield

V6H3V4

British Columbia Children's Hospital BCCH, Vancouver

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

00165

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

All Listed Sponsors
lead

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

INDUSTRY

NCT02682927 - A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome | Biotech Hunter | Biotech Hunter