Clinical Trials

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A Multicenter, Randomized, double-blind, parallel group, placebo- controlled trial of two fixed doses of ZX008 (Fenfluramine hydrochloride) oral solution as an adjunctive therapy in children and young adults with Dravet Syndrome.

Sponsor: Zogenix Pharmacutical
Protocol title: ZX008-1501
PI: Juliann Paolicchi, MD

Key Inclusion /exclusion criteria:

Inclusion Criteria

* Age 2 to 18

* Documented history to support a clinical diagnosis of Dravet Syndrome

* Subject must have had ≥4 convulsive seizures(tonic-clonic, tonic, atonic) per 4 week period for past 12 weeks prior to screening visit

* Subject agrees to provide whole blood sample for Dravet syndrome genetic testing panel

Exclusion Criteria

* Known hypersensitivity to fenfluramine

* Hx of pulmonary hypertension

* Current or past hx of valvular heart disease or cerebrovascular disease

* Subject currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, Phenytoin or phenobarbital