RecruitingPhase 3NCT05066217

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome

Sponsor

Epygenix

Enrollment

260 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Lennox Gastaut Syndrome

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).

Eligibility

Min Age: 2 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Clemizole HCl and a drug called Placebo for people with lennox gastaut syndrome. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 2 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClemizole HCl

Clemizole HCl will be administered as an oral solution.

DRUGPlacebo

Placebo will be administered as an oral solution.

Locations(58)

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

Children's Health Specialty Center

Dallas, Texas, 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 Azienda Ospedaliera Metropolitan

Genoa, Liguria, Italy

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

Childrens University Hospital

Belgrade, Serbia

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

View Full Details on ClinicalTrials.gov

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NCT05066217

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