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A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
Sponsor: Epygenix
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
Last Updated
2026-08-13
Healthy Volunteers
No
Conditions
Interventions
Clemizole HCl
Clemizole HCl will be administered as an oral solution.
Placebo
Placebo will be administered as an oral solution.
Locations (69)
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
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
Buenos Aires, Argentina
Conci Carpinella - Santa Rosa N° 748
Córdoba, Argentina
Instituto Privado Kremer
Córdoba, Argentina
Instituto Médico Rivarola (GIEN SRL)
San Luis, Argentina
Hospital Universitário da Universidade Estadual de Campinas - UNICAMP
Campinas, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, Brazil
Hospital São Paulo da Universidade Federal de Sao Paulo - Escola Paulista de Medicina UNIFESP-EPM
São Paulo, Brazil
Instituto de Psiquiatria HC FMUSP
São Paulo, Brazil
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
Rainbow Children's Hospital
Hyderabad, Andhra Pradesh, India
Yashoda Hospitals Hitec City
Hyderabad, Andhra Pradesh, India
Saachi Children's Hospital
Surat, Gujarat, India
KLES Dr Prabhakar Kore Hospital and Medical Research Centre
Belagavi, Karnataka, India
National Institute of Mental Health and Neurosciences (NIMHANS)
Bengaluru, Karnataka, India
Amrita Institute of Medical Sciences & Research Center
Kochi, Kerala, India
KEM Hospital Research Centre
Pune, Maharashta, India
Jaslok Hospital & Research Centre
Mumbai, Maharashtra, India
Central India Cardiology Hospital and Research Institute
Nagpur, Maharashtra, India
SRCC Children's Hospital
Mahālakshmi, Mumbai, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Christian Medical College
Vellore, Tamil Nadu, India
University Clinical Center in Gdansk, Division of Developmental Neurology
Gdansk, Poland
Medical Centre Plejady
Krakow, Poland
Institute of Mother and Child
Warsaw, Poland
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