A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 15, 2020

Primary Completion Date

April 1, 2026

Study Completion Date

May 1, 2029

Conditions
Dravet Syndrome
Interventions
DRUG

Clemizole HCl

Clemizole HCl will be administered as an oral solution.

DRUG

Placebo

Placebo will be administered as an oral solution.

Trial Locations (46)

1085

RECRUITING

Semmelweis University, Budapest

4032

RECRUITING

University of Debrecen, Debrecen

10021

RECRUITING

Weill Cornell Medical Center, New York

10075

NOT_YET_RECRUITING

Northwell Health - Lenox Hill Hospital, New York

19104

RECRUITING

The Children's Hospital of Philadelphia, Philadelphia

19803

RECRUITING

The Nemours Foundation, Wilmington

27157

RECRUITING

Wake Forest Baptist Medical Center, Winston-Salem

27710

NOT_YET_RECRUITING

Duke University Health System, Durham

28009

RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

30328

NOT_YET_RECRUITING

Clinical Integrative Research Center of Atlanta (CIRCA), Atlanta

32789

NOT_YET_RECRUITING

Pediatric Neurology and Epilepsy Specialists, Winter Park

34746

NOT_YET_RECRUITING

Rare Disease Research FL, Kissimmee

38103

TERMINATED

Le Bonheur Children's Hospital, Memphis

40202

NOT_YET_RECRUITING

Norton Children's Research Institute, Louisville

43205

WITHDRAWN

Nationwide Children's Hospital, Columbus

44195

RECRUITING

Cleveland Clinic, Cleveland

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

48109

WITHDRAWN

University of Michigan- Mott Children's Hospital, Ann Arbor

60611

WITHDRAWN

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

68114

RECRUITING

Children's Nebraska, Omaha

75207

NOT_YET_RECRUITING

UT Southwestern/Children's Health, Dallas

78757

RECRUITING

Child Neurology Consultants of Austin, Austin

84112

RECRUITING

University of Utah, Salt Lake City

90027

TERMINATED

Children's Hospital of Los Angeles, Los Angeles

92868

RECRUITING

University of California Irvine, Orange

94158

RECRUITING

UCSF Medical Center, San Francisco

98105

RECRUITING

Seattle Children's Hospital, Seattle

06510

NOT_YET_RECRUITING

Yale University School of Medicine, New Haven

07601

TERMINATED

Northeast Regional Epilepsy Group, Hackensack

07746

ACTIVE_NOT_RECRUITING

Neurology Center for Epilepsy and Seizures, Marlboro

V6H 3V1

RECRUITING

UBC Children's Hospital Research Institute, Vancouver

K1H 8L1

RECRUITING

Children's Hospital of Eastern Ontario Research Institute Inc., Ottawa

M5G 1X8

RECRUITING

The Hospital for Sick Children, Toronto

M5T 2S8

RECRUITING

Toronto Western Hospital, University Health Network, Toronto

0159

RECRUITING

Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry, Tbilisi

0160

RECRUITING

Medi Club Georgia LLC, Tbilisi

0186

RECRUITING

Institute of Neurology and Neuropsychology LTD, Tbilisi

Unknown

NOT_YET_RECRUITING

University Clinical Center in Gdansk, Division of Developmental Neurology, Gdansk

30-363

RECRUITING

Medical Centre Plejady, Krakow

01-211

RECRUITING

Institute of Mother and Child, Warsaw

041914

NOT_YET_RECRUITING

"Prof. Dr. Al. Obregia Psychiatry Clinical Hospital", Bucharest

08025

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

CF14 4XW

RECRUITING

Cardiff and Vale University Health Board, Cardiff

L12 2AP

NOT_YET_RECRUITING

Alder Hey Children's NHS Foundation Trust, Liverpool

WC1N 1EH

RECRUITING

Great Ormond Street Hospital For Children, London

S102TH

RECRUITING

Sheffield Children's Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Harmony Biosciences Management, Inc.

INDUSTRY

lead

Epygenix

INDUSTRY