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RECRUITING
NCT04462770
PHASE3

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

Sponsor: Epygenix

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

2 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2020-09-15

Completion Date

2029-05-01

Last Updated

2025-08-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

Clemizole HCl

Clemizole HCl will be administered as an oral solution.

DRUG

Placebo

Placebo will be administered as an oral solution.

Locations (46)

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

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

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

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

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

Alder Hey Children's NHS Foundation Trust

Liverpool, United Kingdom

Great Ormond Street Hospital For Children

London, United Kingdom

Sheffield Children's Hospital

Sheffield, United Kingdom