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An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Sponsor: Epygenix
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).
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
Key Details
Gender
All
Age Range
2 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2025-04-09
Completion Date
2029-11-01
Last Updated
2026-08-21
Healthy Volunteers
No
Conditions
Interventions
Clemizole HCl
Clemizole HCl will be administered as an oral solution.
Placebo
Placebo will be administered as an oral solution.
Locations (55)
Arkansas Children's Hospital
Little Rock, Arkansas, United States
UC Irvine Medical Center
Orange, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
AdventHealth Innovation Tower
Orlando, Florida, United States
Rare Disease Research
Orlando, Florida, United States
Pediatric Neurology and Epilepsy Specialists
Winter Park, Florida, United States
Re:Cognition Health
Chicago, Illinois, United States
Norton Children's Medical Center
Louisville, Kentucky, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Epilepsy Group, P.A.
Roseville, Minnesota, United States
Children's Nebraska
Omaha, Nebraska, United States
Tekton Research
Marlboro, New Jersey, United States
NYU Comprehensive Epilepsy Center - BRANY - PPDS
New York, New York, United States
Weill Cornell Medicine/New York Presbyterian Hospital
New York, New York, United States
Atrium Health STRIVE Research
Charlotte, North Carolina, United States
On-Site Clinical Solution
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
PPD Virtual-Science 37, Inc.
Morrisville, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
UTHealth Houston
Houston, Texas, United States
Clinical Neurosciences Center
Salt Lake City, Utah, United States
Peking University First Hospital - Changqiao Campus
Beijing, China
Peking University First Hospital - Daxing Campus
Beijing, China
Beijing Children's Hospital, Capital Medical University - PIN
Beijing, China
The First Hospital of Jilin University
Changchun, China
Hunan Children's Hospital
Changsha, China
West China Second University Hospital, Sichuan University - Huaxi Campus
Chengdu, China
Chengdu Women's and Children's Central Hospital
Chengdu, China
Children's Hospital of Chongqing Medical University
Chongqing, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Qilu Hospital of Shandong University
Jinan, China
Jiangxi Provincial Children's Hospital
Nanchang, China
Shenzhen Children's Hospital
Shenzhen, China
Wuhan Children's Hospital
Wuhan, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xuzhou Children's Hospital
Xuzhou, China
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise, Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
Catanzaro, Italy
Azienda Ospedaliero Universitaria A Meyer
Florence, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Italy
Centrum Medyczne Plejady Magdalena Celinska
Krakow, Lesser Poland Voivodeship, Poland
Neurosphera
Warsaw, Masovian Voivodeship, Poland
Centrul National Clinic De Recuperare Neuropsihomotorie Copii Robanescu-Padure
Bucharest, Romania
Emergency University Hospital
Bucharest, Romania
Sf. Maria Children Emergency Clinical Hospital Iasi
Iași, Romania
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, Serbia
University Clinical Center Nis
Niš, Serbia
Children and Youth Health Care Institute of Vojvodina
Novi Sad, Serbia
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, Spain
Hospital Infantil Universitario Niño Jesus - PIN
Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Centro de Neurologia Avanzada
Seville, Spain