Authors :
#N/A, PharmaWrite; Kim I. Bishop, Global Pharma Consultancy, LLC; Peter K. Isquith, Boston's Children Hospital; Gerard Gioia, Children's National Health System; Glenn Morrison, Zogenix, Inc.; Arnold R. Gammaitoni, Zogenix, Inc.; Douglas Haney, Zogenix, In
Rationale:
Patients with Dravet syndrome (DS) often experience cognitive impairment, including executive function deficits. Although convulsive seizure frequency (CSF) and severity are believed to exacerbate cognitive impairment over time, few long-term studies are available to confirm this conclusion. In a recent phase 3 study, adjunctive fenfluramine (FFA) significantly reduced CSF and improved executive function, an important aspect of behavioral, emotional and cognitive functioning, after 14 weeks in patients with DS. The objective of this analysis was to evaluate: (1) overall relationship between changes in CSF and executive function and (2) impact of reducing CSF by comparing subsets of patients who experienced profound (>=75%) vs minimal (<25%) reductions after 1 year of add-on FFA in an open-label extension (OLE) study.