A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

May 23, 2024

Study Completion Date

May 23, 2024

Conditions
Lennox Gastaut Syndrome
Interventions
DRUG

ZX008 0.2 or 0.8 mg/kg/day

ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.

DRUG

Matching Placebo

Placebo will be administered twice a day (BID) in equally divided doses.

Trial Locations (72)

10016

Ep0214 142, New York

10530

Ep0214 150, Hartsdale

17403

Ep0214 139, York

20010

Ep0214 149, Washington D.C.

20817

Ep0214 140, Bethesda

30328

Ep0214 117, Atlanta

32561

Ep0214 115, Gulf Breeze

32803

Ep0214 141, Orlando

32819

Ep0214 121, Orlando

33155

Ep0214 104, Miami

44106

Ep0214 131, Cleveland

48073

Ep0214 147, Royal Oak

49503

Ep0214 136, Grand Rapids

55102

Ep0214 132, Saint Paul

55905

Ep0214 109, Rochester

60611

Ep0214 110, Chicago

75235

Ep0214 146, Dallas

76104

Ep0214 126, Fort Worth

80045

Ep0214 103, Aurora

84113

Ep0214 106, Salt Lake City

85718

Ep0214 107, Tucson

94158

Ep0214 101, San Francisco

97239

Ep0214 143, Portland

98405

Ep0214 125, Tacoma

90095-1752

Ep0214 144, Los Angeles

02114

Ep0214 112, Boston

07601

Ep0214 105, Hackensack

07039

Ep0214 118, Livingston

19104-4318

Ep0214 120, Philadelphia

78207-3108

Ep0214 145, San Antonio

Unknown

Ep0214 301, Heidelberg

Ep0214 302, South Brisbane

Ep0214 802, Brussels

Ep0214 803, Brussels

Ep0214 801, Edegem

Ep0214 204, Toronto

Ep0214 201, Vancouver

Ep0214 701, Dianalund

Ep0214 1004, Bordeaux

Ep0214 1006, Bron

Ep0214 1005, Lille

Ep0214 1007, Marseille

Ep0214 1001, Paris

Ep0214 1002, Paris

Ep0214 902, Bielefeld

Ep0214 906, Freiburg im Breisgau

Ep0214 905, Jena

Ep0214 908, Kiel

Ep0214 903, Radeberg

Ep0214 901, Vogtareuth

Ep0214 1211, Bologna

Ep0214 1201, Florence

Ep0214 1204, Genova

Ep0214 1206, Roma

Ep0214 1208, Roma

Ep0214 1510, Fukuoka

Ep0214 1505, Niigata

Ep0214 1501, Okayama

Ep0214 1507, Osaka

Ep0214 1504, Ōmura

Ep0214 1508, Sapporo

Ep0214 1506, Shinjuku-ku

Ep0214 1502, Shizuoka

Ep0214 1604, Guadalajara

Ep0214 1401, Zwolle

Ep0214 1702, Bydgoszcz

Ep0214 1701, Krakow

Ep0214 1105, Barcelona

Ep0214 1107, Barcelona

Ep0214 1101, Mirasierra

Ep0214 1102, Pamplona

Ep0214 502, Gothenburg

All Listed Sponsors
lead

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

INDUSTRY

NCT03355209 - A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome | Biotech Hunter | Biotech Hunter