An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome
Recruiting · NCT05066217 · Interventional (participants receive a specific treatment) · Lead sponsor: Epygenix
View the official record on ClinicalTrials.gov →Interventions studied
Clemizole HClPlacebo
What this trial is about
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).
Who can take part
Age range
2 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Key
Exclusion criteria
- Known sensitivity, allergy, or previous exposure to clemizole HCl.
- Known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG) (e.g., recent myocardial infarction, clinically significant arrhythmia).
- Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member.
- Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or progressive central nervous system disease, metabolic illness, recent anoxic episode within the last 6 months requiring resuscitation, or progressive degenerative disease or any other condition, which in the opinion of the investigator, could affect seizure control.
- Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.
- Concomitant use of fenfluramine.
- Prior or concomitant use of lorcaserin.
Where it is running
58 locations listed across 14 US states.
- Arkansas Children's Hospital - Little Rock, Arkansas, United States
- UC Irvine Medical Center - Orange, California, United States
- University of Miami Miller School of Medicine - Miami, Florida, United States
- AdventHealth Innovation Tower - Orlando, Florida, United States
- Rare Disease Research - Orlando, Florida, United States
- Pediatric Neurology and Epilepsy Specialists - Winter Park, Florida, United States
- Re:Cognition Health - Chicago, Illinois, United States
- Norton Children's Medical Center - Louisville, Kentucky, United States
- Henry Ford Hospital - Detroit, Michigan, United States
- Minnesota Epilepsy Group, P.A. - Roseville, Minnesota, United States
- Children's Nebraska - Omaha, Nebraska, United States
- Tekton Research - Marlboro, New Jersey, United States
- NYU Comprehensive Epilepsy Center - BRANY - PPDS - New York, New York, United States
- Weill Cornell Medicine/New York Presbyterian Hospital - New York, New York, United States
- Atrium Health STRIVE Research - Charlotte, North Carolina, United States
- On-Site Clinical Solution - Charlotte, North Carolina, United States
- Duke University Medical Center - Durham, North Carolina, United States
- PPD Virtual-Science 37, Inc. - Morrisville, North Carolina, United States
- Children's Hospital of Philadelphia - Philadelphia, Pennsylvania, United States
- Children's Health Specialty Center - Dallas, Texas, United States
- UTHealth Houston - Houston, Texas, United States
- Clinical Neurosciences Center - Salt Lake City, Utah, United States
- Hospital de La Santa Creu i Sant Pau - Barcelona, Spain
- Hospital Universitario Vall d'Hebron - PPDS - Barcelona, Spain
- Peking University First Hospital - Changqiao Campus - Beijing, China
- Peking University First Hospital - Daxing Campus - Beijing, China
- Beijing Children's Hospital, Capital Medical University - PIN - Beijing, China
- Childrens University Hospital - Belgrade, Serbia
- Mother and Child Health Care Institute of Serbia Dr Vukan Cupic - Belgrade, Serbia
- Centrul National Clinic De Recuperare Neuropsihomotorie Copii Robanescu-Padure - Bucharest, Romania
- Emergency University Hospital - Bucharest, Romania
- Azienda Ospedaliera Universitaria Renato Dulbecco - AO Mater Domini - Catanzaro, Italy
- The First Hospital of Jilin University - Changchun, China
- Hunan Children's Hospital - Changsha, China
- West China Second University Hospital, Sichuan University - Huaxi Campus - Chengdu, China
- Chengdu Women's and Children's Central Hospital - Chengdu, China
- Children's Hospital of Chongqing Medical University - Chongqing, China
- Azienda Ospedaliero Universitaria A Meyer - Florence, Italy
- The Second Affiliated Hospital of Guangzhou Medical University - Guangzhou, China
- The Affiliated Hospital of Guizhou Medical University - Guiyang, China
- Sf. Maria Children Emergency Clinical Hospital Iasi - Iași, Romania
- Qilu Hospital of Shandong University - Jinan, China
- Hospital Infantil Universitario Niño Jesus - PIN - Madrid, Spain
- Fondazione IRCCS Istituto Neurologico Carlo Besta - Milan, Italy
- Hospital Regional Universitario de Malaga - Hospital General - Málaga, Spain
- Jiangxi Provincial Children's Hospital - Nanchang, China
- University Clinical Center Nis - Niš, Serbia
- Children and Youth Health Care Institute of Vojvodina - Novi Sad, Serbia
- Hospital Universitario de Navarra - Pamplona, Spain
- Centro de Neurologia Avanzada - Seville, Spain
- Shenzhen Children's Hospital - Shenzhen, China
- Wuhan Children's Hospital - Wuhan, China
- The Second Affiliated Hospital of Xi'an Jiaotong University - Xi'an, China
- Xuzhou Children's Hospital - Xuzhou, China
- Centrum Medyczne Plejady Magdalena Celinska - Krakow, Lesser Poland Voivodeship, Poland
- IRCCS Azienda Ospedaliera Metropolitan - Genoa, Liguria, Italy
- Neurosphera - Warsaw, Masovian Voivodeship, Poland
- IRCCS Istituto Neurologico Mediterraneo Neuromed - Pozzilli, Molise, Italy