Loading clinical trials...

An Efficacy and Safety Study of Clemizole HCl in Patients With Lennox-Gastaut Syndrome | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients With Lennox-Gastaut Syndrome

NCT05066217•Epygenix

View on ClinicalTrials.gov

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).

Detailed Description

This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole HCl as adjunctive therapy in children and adult participants with LGS. The study will consist of an Observational Period, a Double-Blind (DB) Period, and an optional Open-Label Extension (OLE) Period.

Eligibility

Age

2 - 55 years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (4)

Rare Disease Research

Kissimmee, Florida, United States

Minnesota Epilepsy Group, P.A.

Roseville, Minnesota, United States

Neurology Center for Epilepsy and Seizures

Marlboro, New Jersey, United States

On-Site Clinical Solution

Charlotte, North Carolina, United States

Key Dates

Start Date

April 9, 2025

Primary Completion Date

November 1, 2026

Completion Date

November 1, 2029

Last Updated

December 9, 2025

Enrollment

260

ESTIMATED participants

Conditions

Lennox Gastaut Syndrome

Interventions

Clemizole HCl

DRUG

Placebo

DRUG

Contacts

Juby Philip

CONTACT

(302) 559-4320 clinicaltrials@harmonybiosciences.com

Cindy Sandy

CONTACT

(317) 258-7262 clinicaltrials@harmonybiosciences.com

RNS System LGS Feasibility Study

NCT05339126

EpilepsyLennox Gastaut Syndrome+3 more

View study

ACTIVE_NOT_RECRUITINGNA

Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

NCT06464653

Lennox Gastaut Syndrome

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

RNS System LGS Feasibility Study

Pallidothalamic Tracts Electrical Stimulation for Lennox-Gastaut Syndrome

A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome

Intermediate-Size Expanded Access Protocol (EAP) for LP352

Long-term Cardiac Monitoring in Epilepsy