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

Prior treatment

• Known sensitivity, allergy, or previous exposure to clemizole HCl.
• 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.

Other illness

• 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.

Lab values

• 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.

• 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.