A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

March 8, 2022

Primary Completion Date

November 8, 2027

Study Completion Date

November 8, 2027

Conditions
CDKL5 Deficiency DisorderGeneralized Tonic Clonic SeizureEpileptic SpasmRefractory Seizures
Interventions
DRUG

ZX008 (Fenfluramine Hydrochloride)

ZX008 is supplied as an oral aqueous solution of Fenfluramine Hydrochloride.

DRUG

Matching ZX008 Placebo

Matching ZX008 placebo is supplied as an oral solution.

Trial Locations (46)

19104

Ep0216 120, Philadelphia

20010

Ep0216 149, Washington D.C.

27514

Ep0216 166, Chapel Hill

30329

Ep0216 157, Atlanta

35233

Ep0216 154, Birmingham

38105

Ep0216 124, Memphis

44195

Ep0216 164, Cleveland

48201

Ep0216 134, Detroit

78731

Ep0216 171, Austin

80045

Ep0216 173, Aurora

90095

Ep0216 144, Los Angeles

94158

Ep0216 101, San Francisco

02115

Ep0216 113, Boston

Unknown

Ep0216 2505, Linz

Ep0216 804, Brussels

Ep0216 801, Edegem

Ep0216 2802, Tbilisi

Ep0216 902, Bielefeld

Ep0216 909, Kehl-Kork

Ep0216 908, Kiel

Ep0216 901, Vogtareuth

Ep0216 1803, Dublin

Ep0216 1909, Petah Tikva

Ep0216 1906, Ramat Gan

Ep0216 1904, Tel Aviv

Ep0216 1201, Florence

Ep0216 1204, Genova

Ep0216 1212, Modena

Ep0216 1206, Roma

Ep0216 1208, Roma

Ep0216 1202, Verona

Ep0216 1512, Hiroshima

Ep0216 1505, Niigata

Ep0216 1518, Ōmura

Ep0216 1502, Shizuoka

Ep0216 1401, Zwolle

Ep0216 2104, Lisbon

Ep0216 2105, Porto

Ep0216 1103, Barcelona

Ep0216 1117, Madrid

Ep0216 1118, Santiago de Compostela

Ep0216 3101, Dubai

Ep0216 607, Bristol

Ep0216 602, London

Ep0216 611, Manchester

Ep0216 604, Sheffield

All Listed Sponsors
lead

Zogenix, Inc.

INDUSTRY