A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

412

Participants

Timeline

Start Date

April 22, 2019

Primary Completion Date

May 8, 2025

Study Completion Date

May 8, 2025

Conditions
Dravet SyndromeLennox Gastaut SyndromeEpileptic Encephalopathy
Interventions
DRUG

ZX008 (Fenfluramine Hydrochloride)

Fenfluramine hydrochloride provided in a concentration of 2.5 mg/mL.

Trial Locations (71)

10016

Ep0215 142, New York

10532

Ep0215 150, Hawthorne

20817

Ep0215 140, Bethesda

30328

Ep0215 117, Atlanta

32561

Ep0215 115, Gulf Breeze

32789

Ep0215 121, Winter Park

32803

Ep0215 141, Orlando

33155

Ep0215 104, Miami

38103

Ep0215 124, Memphis

44106

Ep0215 131, Cleveland

55113

Ep0215 132, Roseville

55905

Ep0215 109, Rochester

75207

Ep0215 146, Dallas

76104

Ep0215 126, Fort Worth

80045

Ep0215 103, Aurora

84108

Ep0215 106, Salt Lake City

85718

Ep0215 107, Tucson

90095

Ep0215 144, Los Angeles

92123

Ep0215 108, San Diego

94158

Ep0215 101, San Francisco

98105

Ep0215 119, Seattle

98405

Ep0215 125, Tacoma

60611-2605

Ep0215 110, Chicago

02114

Ep0215 112, Boston

07601

Ep0215 105, Hackensack

07039

Ep0215 118, Livingston

Unknown

Ep0215 301, Heidelberg

Ep0215 302, South Brisbane

Ep0215 303, Westmead

Ep0215 803, Brussels

Ep0215 801, Edegem

Ep0215 802, Jette

Ep0215 202, Montreal

Ep0215 204, Toronto

Ep0215 201, Vancouver

Ep0215 701, Dianalund

Ep0215 1004, Bordeaux

Ep0215 1005, Lille

Ep0215 1007, Marseille

Ep0215 1001, Paris

Ep0215 1002, Paris

Ep0215 1008, Salouël

Ep0215 902, Bielefeld

Ep0215 906, Freiburg im Breisgau

Ep0215 905, Jena

Ep0215 908, Kiel

Ep0215 903, Radeberg

Ep0215 901, Vogtareuth

Ep0215 1201, Florence

Ep0215 1204, Genova

Ep0215 1205, Mantova

Ep0215 1207, Milan

Ep0215 1206, Roma

Ep0215 1208, Roma

Ep0215 1202, Verona

Ep0215 1604, Guadalajara

Ep0215 1402, Heeze

Ep0215 1401, Zwolle

Ep0215 1702, Bydgoszcz

Ep0215 1701, Krakow

Ep0215 1105, Barcelona

Ep0215 1107, Barcelona

Ep0215 1103, Esplugues de Llobregat

Ep0215 1101, Madrid

Ep0215 1102, Pamplona

Ep0215 502, Gothenburg

Ep0215 605, Birmingham

Ep0215 601, Glasgow

Ep0215 603, Liverpool

Ep0215 602, London

Ep0215 606, London

All Listed Sponsors
collaborator

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

INDUSTRY

lead

Zogenix, Inc.

INDUSTRY

NCT03936777 - A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome | Biotech Hunter | Biotech Hunter