Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome
Who is this study for? Children with Lennox-Gastaut syndrome
What treatments are being studied? Clemizole HCl
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 55
Healthy Volunteers: f
View:
• Males or females, ages ≥2 to ≤55 years, at the time of Screening.
• Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent.
• Diagnosis of LGS, including:
‣ Evidence of at least one type of countable major motor seizure.
⁃ History of electroencephalogram (EEG) consistent with LGS (abnormal background activity, and one of the following: 1) slow spike-wave discharges \[\<2.5 Hz\], or 2) paroxysmal fast activity during sleep).
⁃ Abnormal cognitive development.
⁃ Onset of seizures at 11 years of age or younger.
Locations
United States
Arkansas
Arkansas Children's Hospital
ACTIVE_NOT_RECRUITING
Little Rock
California
UC Irvine Medical Center
ACTIVE_NOT_RECRUITING
Orange
Florida
University of Miami Miller School of Medicine
RECRUITING
Miami
AdventHealth Innovation Tower
RECRUITING
Orlando
Rare Disease Research
SUSPENDED
Orlando
Pediatric Neurology and Epilepsy Specialists
ACTIVE_NOT_RECRUITING
Winter Park
Illinois
Re:Cognition Health
RECRUITING
Chicago
Kentucky
Norton Children's Medical Center
RECRUITING
Louisville
Michigan
Henry Ford Hospital
ACTIVE_NOT_RECRUITING
Detroit
Minnesota
Minnesota Epilepsy Group, P.A.
RECRUITING
Roseville
North Carolina
Atrium Health STRIVE Research
RECRUITING
Charlotte
On-Site Clinical Solution
RECRUITING
Charlotte
Duke University Medical Center
RECRUITING
Durham
PPD Virtual-Science 37, Inc.
RECRUITING
Morrisville
Nebraska
Children's Nebraska
RECRUITING
Omaha
New Jersey
Tekton Research
RECRUITING
Marlboro
New York
NYU Comprehensive Epilepsy Center - BRANY - PPDS
RECRUITING
New York
Weill Cornell Medicine/New York Presbyterian Hospital
RECRUITING
New York
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
UTHealth Houston
RECRUITING
Houston
Utah
Clinical Neurosciences Center
RECRUITING
Salt Lake City
Other Locations
China
Beijing Children's Hospital, Capital Medical University - PIN
RECRUITING
Beijing
Peking University First Hospital - Changqiao Campus
RECRUITING
Beijing
Peking University First Hospital - Daxing Campus
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
Hunan Children's Hospital
RECRUITING
Changsha
Chengdu Women's and Children's Central Hospital
RECRUITING
Chengdu
West China Second University Hospital, Sichuan University - Huaxi Campus
RECRUITING
Chengdu
Children's Hospital of Chongqing Medical University
RECRUITING
Chongqing
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Qilu Hospital of Shandong University
RECRUITING
Jinan
Jiangxi Provincial Children's Hospital
RECRUITING
Nanchang
Shenzhen Children's Hospital
RECRUITING
Shenzhen
Wuhan Children's Hospital
RECRUITING
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Xuzhou Children's Hospital
RECRUITING
Xuzhou
Italy
Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini
RECRUITING
Catanzaro
Azienda Ospedaliero Universitaria A Meyer
RECRUITING
Florence
Fondazione IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
IRCCS Istituto Neurologico Mediterraneo Neuromed
RECRUITING
Pozzilli
Poland
Centrum Medyczne Plejady Magdalena Celinska
RECRUITING
Krakow
Neurosphera
RECRUITING
Warsaw
Romania
Centrul National Clinic De Recuperare Neuropsihomotorie Copii Robanescu-Padure
RECRUITING
Bucharest
Emergency University Hospital
RECRUITING
Bucharest
Sf. Maria Children Emergency Clinical Hospital Iasi
RECRUITING
Iași
Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
RECRUITING
Belgrade
University Clinical Center Nis
RECRUITING
Niš
Children and Youth Health Care Institute of Vojvodina
RECRUITING
Novi Sad
Spain
Hospital de La Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
RECRUITING
Barcelona
Hospital Infantil Universitario Niño Jesus - PIN
RECRUITING
Madrid
Hospital Regional Universitario de Malaga - Hospital General
RECRUITING
Málaga
Hospital Universitario de Navarra
RECRUITING
Pamplona
Centro de Neurologia Avanzada
RECRUITING
Seville
Contact Information
Primary
Juby Philip
clinicaltrials@harmonybiosciences.com
(302) 559-4320
Backup
Cindy Sandy
clinicaltrials@harmonybiosciences.com
(317) 258-7262
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2029-11-01
Participants
Target number of participants: 260
Treatments
Placebo_comparator: Placebo
Participants will receive their first dose of study drug following randomization.
Experimental: Double-blind clemizole HCl
Participants will receive their first dose of study drug following randomization.
Experimental: Open-label clemizole HCl
Eligible participants who complete the DB Period will have the option to continue in the OLE Period, during which they will receive clemizole HCl for up to 3 years.
Related Therapeutic Areas
Sponsors
Leads: Epygenix
Collaborators: Harmony Biosciences Management, Inc.