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
UCI Center for Innovative Health Therapies
Orange, California 92868
United States
Nemours Children's Health
Wilmington, Delaware 19803
United States
Rare Disease Research
Kissimmee, Florida 34746
United States
University of Miami Miller School of Medicine
Miami, Florida 33136
United States
AdventHealth Innovation Tower
Orlando, Florida 32804
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
Neurology Center for Epilepsy and Seizures
Marlboro, New Jersey 07746
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
UTHealth Houston
Houston, Texas 77030
United States
Clinical Neurosciences Center
Salt Lake City, Utah 84132
United States
IRCCS Istituto Neurologico Mediterraneo Neuromed
Pozzilli, Molise 86077
Italy
Neurosphera
Warsaw, Masovian Voivodeship 02-829
Poland