About this trial
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 criteria
Qualifiers
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.
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Clemizole HCl
- Placebo
Treatment groups
Sponsors and collaborators
Epygenix
Lead sponsor
Harmony Biosciences Management, Inc.
Collaborator