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

Key Inclusion Criteria:

- Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day
of the Screening Visit.

- Clinical diagnosis of Dravet syndrome, where convulsive seizures are not completely
controlled by current antiepileptic drugs.

- Must have a minimum # of convulsive seizures per 4-week period for past 12 weeks prior
to screening

- All medications or interventions for epilepsy must be stable for at least 4 weeks
prior to screening and expected to remain stable throughout the study.

- No cardiovascular or cardiopulmonary abnormality based on ECHO, ECG or physical
examination

- Parent/caregiver is willing and able to be compliant with diary completion, visit
schedule and study drug accountability.

Key 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.