NCT02926898 - A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 27, 2017

Primary Completion Date

June 5, 2018

Study Completion Date

June 5, 2018

Conditions

Dravet Syndrome

Interventions

DRUG

ZX008 (Fenfluramine Hydrochloride)

"ZX008 0.5 mg/kg/day (maximum 20 mg/day). ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 2.5 mg/mL.~\*Note: The 0.5 mg/kg/day dose of ZX008 fenfluramine hydrochloride in this study is equivalent to 0.4 mg/kg/day (maximum 17 mg/day) dose of fenfluramine base."

DRUG

Matching Placebo

Trial Locations (28)

13385

Hôpital de La Timone, Service de Neuro-Métabolisme Pédiatrique, Marseille

24105

Universitätsklinikum Schleswig-Holstein, Klinik Für Neuropädiatrie, Kiel

28034

Hospital Ruber Internacional-Servicio de Neurología, Madrid

31008

Cliníca Universidad de Navarra Nidad de Neuropediatría, Pamplona

31059

Chu de Toulouse - Hôpital Des Enfants, Toulouse

33076

Chu de Bordeaux Hôpital Des Enfants, Bordeaux

33617

Krankenhaus Mara, Epilepsie-Zentrum Bethel, Bielefeld

48201

Children'S Hospital of Michigan, Detroit

54511

Hôpital D'Enfants Chur de Nancy, Vandœuvre-lès-Nancy

55905

Mayo Clinic, Rochester

59037

Chru de Lille Hôpital Roger Salengro, Lille

60611

Ann & Robert H. Lurie Children'S Hospital of Chicago, Chicago

69677

HÔPITAL FEMME-MÈRE-ENFANT Hôpital Service de Neurologie Pédiatrique, Bron

75015

Hôpital Necker-Enfants Malades, Paris

75019

Hôpital Robert-Debré, Paris

80045

Children'S Hospital Colorado, Aurora

80480

Chu Amiens Picardie Service de Neurologie Pédiatrique, Amiens

94158

University of California San Francisco, San Francisco

V6H 3V4

Bc Children'S Hospital Division of Neurology, Vancouver

H3T 1C5

Chu Sainte-Justine Hospital Neurology Clinic, Montreal

01454

Kleinwachau Sächsisches Epilepsiezentrum Radeberg, Radeberg

5591 VE

Epilepsiecentrum Kempenhaeghe, Heeze

8025 BV

Stichting Epilepsie Instellingen Nederland, Zwolle

08950

Hospital Sant Joan de Déu Barcelona, Barcelona

G51 4TF

Royal Hospital For Children, Queen Elizabeth University, Institute of Neurosciences Hospital, Glasgow

L12 2AP

Alder Hey Children'S Nhs Foundation Trust, Littlewood'S Neurosciences Unit, Liverpool

SE1 7EH

Evelina London Children'S Hospital, Paediatric Neurosciences, London

WC1N 3JH

Great Ormond Street Hospital For Children Nhs Foundation Trust, London

All Listed Sponsors

lead

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

INDUSTRY