RecruitingPhase 3NCT04462770

A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)

Sponsor

Epygenix

Enrollment

150 participants

Start Date

Sep 15, 2020

Study Type

INTERVENTIONAL

Conditions

Dravet Syndrome

Summary

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).

Eligibility

Min Age: 2 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 dravet syndrome. The study is currently recruiting participants at 58 locations. People eligible for this study include aged 2 Years and older.

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(60)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

University of California Irvine

Orange, California, United States

UCSF Medical Center

San Francisco, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Yale School of Medicine - Yale-New Haven Hospital

New Haven, Connecticut, United States

The Nemours Foundation

Wilmington, Delaware, United States

Rare Disease Research FL

Kissimmee, Florida, United States

Pediatric Neurology and Epilepsy Specialists

Winter Park, Florida, United States

Clinical Integrative Research Center of Atlanta (CIRCA)

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Norton Children's Research Institute

Louisville, Kentucky, United States

University of Michigan- Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Nebraska

Omaha, Nebraska, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

Neurology Center for Epilepsy and Seizures

Marlboro, New Jersey, United States

Weill Cornell Medical Center

New York, New York, United States

Northwell Health - Lenox Hill Hospital

New York, New York, United States

Duke University Health System

Durham, North Carolina, United States

Science 37

Morrisville, North Carolina, United States

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Le Bonheur Children's Hospital

Memphis, Tennessee, United States

Child Neurology Consultants of Austin

Austin, Texas, United States

UT Southwestern/Children's Health

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Medical College of Wisconsin, Children's Wisconsin

Milwaukee, Wisconsin, United States

UBC Children's Hospital Research Institute

Vancouver, British Columbia, Canada

Children's Hospital of Eastern Ontario Research Institute Inc.

Ottawa, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry

Tbilisi, Georgia

Medi Club Georgia LLC

Tbilisi, Georgia

Institute of Neurology and Neuropsychology LTD

Tbilisi, Georgia

Semmelweis University

Budapest, Hungary

University of Debrecen

Debrecen, Hungary

Saachi Children's Hospital

Surat, Gujarat, India

National Institute of Mental Health and Neurosciences (NIMHANS)

Adugodi, Karnatka, India

Central India Cardiology Hospital and Research Institute

Nagpur, Maharashtra, India

All India Institute of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi, India

Christian Medical College

Vellore, Tamil Nadu, India

Rainbow Children's Hospital

Hyderabad, India

Amrita Institute of Medical Sciences & Research Center

Kochi, India

Jaslok Hospital & Research Centre

Mumbai, India

SRCC Children's Hospital by NH

Mumbai, India

All India Institute of Medical Sciences

New Delhi, India

University Clinical Center in Gdansk, Division of Developmental Neurology

Gdansk, Poland

Medical Centre Plejady

Krakow, Poland

Institute of Mother and Child

Warsaw, Poland

"Prof. Dr. Al. Obregia" Psychiatry Clinical Hospital

Bucharest, Romania

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid Provincia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Great Ormond Street Hospital For Children

London, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04462770

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