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(26)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

UC Irvine Medical Center

Orange, California, United States

UCI Center for Innovative Health Therapies

Orange, California, United States

Nemours Children's Health

Wilmington, Delaware, United States

Rare Disease Research

Kissimmee, Florida, United States

University of Miami Miller School of Medicine

Miami, Florida, United States

AdventHealth Innovation Tower

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

Neurology Center for Epilepsy and Seizures

Marlboro, New Jersey, 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

IRCCS Istituto Neurologico Mediterraneo Neuromed

Pozzilli, Molise, Italy

Neurosphera

Warsaw, Masovian Voivodeship, Poland

View Full Details on ClinicalTrials.gov

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NCT05066217

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