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

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.