An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Start Date
4/9/2025
Completion Date
11/1/2029
Summary
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCL (EPX-100) as adjunctive therapy in children and adult participants with Lennox-Gastaut syndrome (LGS).
Detailed Description
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCl as adjunctive therapy in children and adult participants with LGS. The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.
Eligibility Criteria
Age Range: 2 years to 55 years
Interventions
Clemizole HCl
Placebo
Conditions
Locations
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United States
UC Irvine Medical Center
Orange, California 92868
United States
University of Miami Miller School of Medicine
Miami, Florida 33136
United States
AdventHealth Innovation Tower
Orlando, Florida 32804
United States
Rare Disease Research
Orlando, Florida 34746
United States
Pediatric Neurology and Epilepsy Specialists
Winter Park, Florida 32789
United States
Re:Cognition Health
Chicago, Illinois 60611
United States
Norton Children's Medical Center
Louisville, Kentucky 40202
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota 55102
United States
Children's Nebraska
Omaha, Nebraska 68114
United States
Tekton Research
Marlboro, New Jersey 07746
United States
NYU Comprehensive Epilepsy Center - BRANY - PPDS
New York, New York 10016-4852
United States
Weill Cornell Medicine/New York Presbyterian Hospital
New York, New York 10021
United States
Atrium Health STRIVE Research
Charlotte, North Carolina 28207
United States
On-Site Clinical Solution
Charlotte, North Carolina 28211
United States
Duke University Medical Center
Durham, North Carolina 27705
United States
PPD Virtual-Science 37, Inc.
Morrisville, North Carolina 27560
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Children's Health Specialty Center
Dallas, Texas 75235
United States
UTHealth Houston
Houston, Texas 77030
United States
Clinical Neurosciences Center
Salt Lake City, Utah 84132
United States
Peking University First Hospital - Changqiao Campus
Beijing, 100034
China
Peking University First Hospital - Daxing Campus
Beijing, 100034
China
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, 100045
China
The First Hospital of Jilin University
Changchun, 130021
China
Hunan Children's Hospital
Changsha, 410007
China
West China Second University Hospital, Sichuan University - Huaxi Campus
Chengdu, 610041
China
Chengdu Women's and Children's Central Hospital
Chengdu, 610073
China
Children's Hospital of Chongqing Medical University
Chongqing, 400014
China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510260
China
The Affiliated Hospital of Guizhou Medical University
Guiyang, 550004
China
Qilu Hospital of Shandong University
Jinan, 250012
China
Jiangxi Provincial Children's Hospital
Nanchang, 330006
China
Shenzhen Children's Hospital
Shenzhen, 518000
China
Wuhan Children's Hospital
Wuhan, 430015
China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710004
China
Xuzhou Children's Hospital
Xuzhou, 221006
China
Yashoda Hospitals Hitec City
Hyderabad, Andhra Pradesh 500081
India
Nizams Institute of Medical Sciences
Hyderabad, Andhra Pradesh 500082
India
Saachi Children Hospital
Surat, Gujarat 395002
India
IRCCS Azienda Ospedaliera Metropolitan
Genoa, Liguria 16132
Italy
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise 86077
Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, 88100
Italy
Azienda Ospedaliero Universitaria A Meyer
Florence, 50139
Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Italy
Centrum Medyczne Plejady Magdalena Celinska
Krakow, Lesser Poland Voivodeship 30-363
Poland
Neurosphera
Warsaw, Masovian Voivodeship 02-829
Poland
Centrul National Clinic De Recuperare Neuropsihomotorie Copii Robanescu-Padure
Bucharest, 041408
Romania
Emergency University Hospital
Bucharest, 050098
Romania
Sf. Maria Children Emergency Clinical Hospital Iasi
Iași, 700309
Romania
Childrens University Hospital
Belgrade, 11000
Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, 11000
Serbia
University Clinical Center Nis
Niš, 18 000
Serbia
Children and Youth Health Care Institute of Vojvodina
Novi Sad, 21000
Serbia
Hospital de La Santa Creu i Sant Pau
Barcelona, 08025
Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
Spain
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, 28009
Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, 29010
Spain
Hospital Universitario de Navarra
Pamplona, 31008
Spain
Centro de Neurologia Avanzada
Seville, 41013
Spain