RecruitingPhase 3

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

United States260 participantsStarted 2025-04-09

Plain-language 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).

Who can participate

Age range2 Years – 55 Years

SexALL

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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:

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.

What they're measuring

Percent Change in CMMS-28

Timeframe: From Baseline Period up to 16 weeks

Trial details

NCT IDNCT05066217

SponsorEpygenix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Juby Philip

(302) 559-4320 clinicaltrials@harmonybiosciences.com

View on ClinicalTrials.gov More Lennox Gastaut Syndrome trials