Phase
Condition
Seizure Disorders (Pediatric)
Unverricht-lundborg Syndrome
Dravet Syndrome
Treatment
EPX-100 (clemizole HCl)
EPX-100 (Clemizole HCl)
Clemizole HCl
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Male and female participants 2 years and older at time of consent.
Participant or parent/legally authorized representative (LAR) willing and able toprovide written informed consent, assent (if applicable) prior to initiation of anystudy related procedures.
Clinical diagnosis of Dravet syndrome. Participants must have seizures which are notcompletely controlled by AEDs with the following criteria:
Onset of seizures prior to 18 months of age,
Normal development at onset,
History of at least one type of countable motor seizure (CMS),
Brain MRI without cortical malformation (not including mild atrophy associatedwith the natural progression of Dravet syndrome),
Genetic mutation of the SCN1A gene must be documented.
Exclusion
Key Exclusion Criteria:
Known sensitivity, allergy, or previous exposure to clemizole HCl.
Exposure to any investigational drug or device <90 days prior to screening or plansto participate in another drug or device trial at any time during the study.
Seizures secondary to illicit drug (this includes concomitant use oftetrahydrocannabinol [THC] and nonprescription cannabidiol preparations) or alcoholuse, infection, neoplasm, demyelinating disease, degenerative neurological disease,or central nervous system (CNS) disease deemed progressive, metabolic illness, orprogressive degenerative disease.
Prior or concurrent use of lorcaserin.
Concurrent use of fenfluramine.
Epilepsy surgery planned during the study or epilepsy surgery within 6 months priorto Screening.
Study Design
Study Description
Connect with a study center
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia V6H 3V4
CanadaActive - Recruiting
UBC Children's Hospital Research Institute
Vancouver, British Columbia V6H 3V4
CanadaActive - Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario K1H 8L1
CanadaActive - Recruiting
Children's Hospital of Eastern Ontario Research Institute Inc.
Ottawa, Ontario K1H 8L1
CanadaActive - Recruiting
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
CanadaActive - Recruiting
Toronto Western Hospital, University Health Network
Toronto, Ontario M5T 2S8
CanadaActive - Recruiting
Institute of Neurology and Neuropsychology
Tbilisi, 0186
GeorgiaActive - Recruiting
LEPL Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry
Tbilisi, 0159
GeorgiaActive - Recruiting
LTD Institute of Neurology and Neuropsychology
Tbilisi, 0186
GeorgiaActive - Recruiting
LTD Medi Club Georgia LLC
Tbilisi, 0160
GeorgiaSite Not Available
Medi Club Georgia LLC
Tbilisi, 0160
GeorgiaActive - Recruiting
Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry
Tbilisi, 0159
GeorgiaActive - Recruiting
Semmelweis University
Budapest, 1085
HungaryActive - Recruiting
Semmelweis University First Department of Pediatrics, Division of Child Neurology
Budapest, 1083
HungarySite Not Available
University of Debrecen
Debrecen, 4032
HungaryActive - Recruiting
University Clinical Center in Gdansk, Division of Developmental Neurology
Gdańsk,
PolandSite Not Available
Medical Centre Plejady
Kraków, 30-363
PolandActive - Recruiting
Institute of Mother and Child
Warsaw, 01-211
PolandActive - Recruiting
"Prof. Dr. Al. Obregia" Psychiatry Clinical Hospital
Bucharest, 041914
RomaniaSite Not Available
Hospital Universitario Infantil Niño Jesús
Madrid, Madrid Provincia 28009
SpainActive - Recruiting
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid provincia 28009
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
SpainActive - Recruiting
Cardiff and Vale University Health Board
Cardiff, CF14 4XW
United KingdomSite Not Available
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 2AP
United KingdomSite Not Available
Great Ormond Street Hospital For Children
London, WC1N 1EH
United KingdomActive - Recruiting
Sheffield Children's Hospital
Sheffield, S102TH
United KingdomActive - Recruiting
Children's Hospital of Los Angeles
Los Angeles, California 90027
United StatesTerminated
University of California Irvine
Orange, California 92868
United StatesSite Not Available
UCSF Medical Center
San Francisco, California 94158
United StatesActive - Recruiting
Nemours Children's Hospital-DE
Wilmington, Delaware 19803
United StatesActive - Recruiting
The Nemours Foundation
Wilmington, Delaware 19803
United StatesActive - Recruiting
Rare Disease Research FL
Kissimmee, Florida 34746
United StatesSite Not Available
Pediatric Neurology and Epilepsy Specialists
Winter Park, Florida 32789
United StatesSite Not Available
Clinical Integrative Research Center of Atlanta (CIRCA)
Atlanta, Georgia 30328
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United StatesSite Not Available
Norton Children's Research Institute
Louisville, Kentucky 40202
United StatesSite Not Available
University of Michigan- Mott Children's Hospital
Ann Arbor, Michigan 48109
United StatesSite Not Available
Children's Hospital & Medical Center
Omaha, Nebraska 68114
United StatesSite Not Available
Children's Nebraska
Omaha, Nebraska 68114
United StatesActive - Recruiting
NorthEast Epilepsy Group
Hackensack, New Jersey 07601
United StatesSite Not Available
Northeast Regional Epilepsy Group
Hackensack, New Jersey 07601
United StatesTerminated
Neurology Center for Epilepsy and Seizures
Marlboro, New Jersey 07746
United StatesSite Not Available
Weill Cornell Medical Center
New York, New York 10021
United StatesActive - Recruiting
Weill Cornell Medicine/New York-Presbyterian Hospital
New York, New York 10065
United StatesSite Not Available
OnSite Clinical Solutions, LLC
Charlotte, North Carolina 28211
United StatesSite Not Available
Duke University Health System
Durham, North Carolina 27710
United StatesSite Not Available
Wake Forest Baptist Health Sciences Department of Neurology
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesActive - Recruiting
Nationwide Children's Hospital
Columbus, Ohio 43205
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee 38103
United StatesTerminated
Child Neurology Consultants of Austin
Austin, Texas 78757
United StatesActive - Recruiting
UT Southwestern/Children's Health
Dallas, Texas 75207
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84112
United StatesActive - Recruiting
Seattle Children's
Seattle, Washington 98105
United StatesActive - Recruiting
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting
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