Zogenix has completed enrolling patients for its second Phase lll clinical trial, which is designed to assess ZX008 (low-dose fenfluramine) as an adjunctive treatment for seizures in children and young adults with Dravet syndrome.
Completion was achieved after randomising the last patient into the treatment period of study 1504.
The double-blind, randomised, two arm study expects to enrol around 40 subjects per treatment group.
It is being conducted across different sites in the US, France, Spain, the Netherlands, UK, Canada, and Germany, with all subjects given stiripentol as part of their baseline standard of care.
As part of Study 1504, randomised subjects are titrated to an active dose of 0.5mg/kg/day of ZX008 or placebo, over three weeks and then held at that fixed-dose for 12 weeks of maintenance treatment.
Primary efficacy measure of the trial includes a comparison of the change in monthly convulsive seizure frequency between ZX008 and placebo during the treatment period compared with the baseline observation period.
Zogenix CEO and president Stephen Farr said: “We expect to announce top-line data from this study in the second quarter of this year.
“The data generated to date from the Phase lll clinical programme has further strengthened our confidence in the potential of ZX008 to become an important treatment option for the control of seizures in patients suffering from Dravet syndrome, a rare and catastrophic form of epilepsy.”
Study 1504 follows positive top-line data announced last year from the first Phase lll trial of ZX008, Study 1, which met the primary efficacy endpoint, as well as all prespecified key secondary efficacy endpoints.