Clinical Trials

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An Open Label-Extension trial to assess the long-term safety of ZX008 (Fenfluramine Hydrochloride) oral solution as an Adjunctive Therapy in children and young adults with Dravet Syndrome.

PI: Juliann Paolicchi, MD

Sponsor: Zogenix  Pharmaceutical

Prototol: ZX008-1503

Key Inclusion Criteria:

* Subject has satisfactorily completed the core study in the opinion of the  Investigator and the Sponsor.

* Subject's parent/ caregiver has been compliant with diary completion during the core study in the opinion of the investigator (eg, at least 90% compliant).

* Age 2 to 18

Exclusion Criteria:

* Known Hypersensitivity to fenfluramine

* Hx of pulmonary Hypertension

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

 

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