A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome

Exclusion Criteria

• •Pulmonary arterial hypertension.
• •Current or past history of cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction or stroke.
• •Current or past history of glaucoma.
• •Moderate or severe hepatic impairment.
• •Receiving concomitant therapy with: anorectic agents; monoamine-oxidase inhibitors; medications that act via serotonin including serotonin reuptake inhibitors; atomoxetine, or other centrally-acting noradrenergic agonist; or cyproheptadine.
• •Currently receiving or has received stiripentol in the past 21 days prior to Screening.
• •Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days.
• •Positive result on tetrahydrocannabinol (THC) or cannabidiol (CBD) test at the Screening Visit.
• •A clinically significant medical condition,that would interfere with study participation, collection of study data, or pose a risk to the subject.