A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome

Exclusion Criteria

• •1. Known sensitivity, allergy, or previous exposure to clemizole HCl.
• •2. Exposure to any investigational drug or device \<90 days prior to screening or plans to participate in another drug or device trial at any time during the study.
• •3. Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol \[THC\] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.
• •4. Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.
• •5. Concurrent use of fenfluramine.
• •6. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.