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Clinical Trials in the USA / NCT05066217
Recruiting Phase 3

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome

NCT05066217 · tracked via the Priya Life Science USA tracker
Sponsor
Epygenix
Phase
Phase 3
Started
2025-04-09
Last updated
2026-09-15

Condition(s) studied

Lennox Gastaut Syndrome

Investigational drug(s) / intervention(s)

Clemizole HClPlacebo

Clemizole HCl: Clemizole HCl will be administered as an oral solution.

Placebo: Placebo will be administered as an oral solution.

Study 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

Sex
ALL
Min age
2 Years
Max age
55 Years
Healthy volunteers
No
Key Inclusion Criteria: 1. Males or females, ages ≥2 to ≤55 years, at the time of Screening. 2. Participant/parent/legal authorized representative (LAR) willing and able to give written informed consent/assent. 3. 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: 1. Known sensitivity, allergy, or previous exposure to clemizole HCl. 2. 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). 3. Family history of sudden cardiac death, unexplained death, or death from a primary dysrhythmia potentially associated with QT prolongation in any family member. 4. 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. 5. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening. 6. Concomitant use of fenfluramine. 7. Prior or concomitant use of lorcaserin.

Primary outcome measure(s)

Trial sites (58)

FacilityCityRegionStatus
Arkansas Children's Hospital Little Rock Arkansas Active Not Recruiting
UC Irvine Medical Center Orange California Active Not Recruiting
University of Miami Miller School of Medicine Miami Florida Recruiting
AdventHealth Innovation Tower Orlando Florida Recruiting
Rare Disease Research Orlando Florida Suspended
Pediatric Neurology and Epilepsy Specialists Winter Park Florida Active Not Recruiting
Re:Cognition Health Chicago Illinois Recruiting
Norton Children's Medical Center Louisville Kentucky Recruiting
Henry Ford Hospital Detroit Michigan Active Not Recruiting
Minnesota Epilepsy Group, P.A. Roseville Minnesota Recruiting
Children's Nebraska Omaha Nebraska Recruiting
Tekton Research Marlboro New Jersey Recruiting
NYU Comprehensive Epilepsy Center - BRANY - PPDS New York New York Recruiting
Weill Cornell Medicine/New York Presbyterian Hospital New York New York Recruiting
Atrium Health STRIVE Research Charlotte North Carolina Recruiting
On-Site Clinical Solution Charlotte North Carolina Recruiting
Duke University Medical Center Durham North Carolina Recruiting
PPD Virtual-Science 37, Inc. Morrisville North Carolina Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Children's Health Specialty Center Dallas Texas Recruiting
UTHealth Houston Houston Texas Recruiting
Clinical Neurosciences Center Salt Lake City Utah Recruiting
Peking University First Hospital - Changqiao Campus Beijing China Recruiting
Peking University First Hospital - Daxing Campus Beijing China Recruiting
Beijing Children's Hospital, Capital Medical University - PIN Beijing China Recruiting
The First Hospital of Jilin University Changchun China Recruiting
Hunan Children's Hospital Changsha China Recruiting
West China Second University Hospital, Sichuan University - Huaxi Campus Chengdu China Recruiting
Chengdu Women's and Children's Central Hospital Chengdu China Recruiting
Children's Hospital of Chongqing Medical University Chongqing China Recruiting
The Second Affiliated Hospital of Guangzhou Medical University Guangzhou China Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang China Recruiting
Qilu Hospital of Shandong University Jinan China Recruiting
Jiangxi Provincial Children's Hospital Nanchang China Recruiting
Shenzhen Children's Hospital Shenzhen China Recruiting
Wuhan Children's Hospital Wuhan China Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an China Recruiting
Xuzhou Children's Hospital Xuzhou China Recruiting
IRCCS Azienda Ospedaliera Metropolitan Genoa Liguria Recruiting
IRCCS Istituto Neurologico Mediterraneo Neuromed Pozzilli Molise Recruiting

+ 18 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05066217 on ClinicalTrials.gov ↗ ← All trials in the USA