US-based pharmaceutical company Zogenix has begun the multi-national second Phase III clinical trial to evaluate the company's product, ZX008, to treat Dravet syndrome.
The Phase III programme, known as Study 1502, will enrol 105 subjects with 35 patients allocated to each of its two randomised, double-blind, placebo-controlled studies to assess ZX008, which will be administered in two dosages, 0.2 mg/kg per day and 0.8 mg/kg per day to a maximum of 30mg dose, as well as placebo.
Both of the studies under the Phase III programme focuses on two endpoints.
The primary endpoint is the change in the occurrence of convulsive seizures compared to placebo and the secondary endpoint, which includes 40% and 50% responder analyses, considered necessary for European regulatory submissions, as well as the interval between occurrences of a convulsive seizure.
Multi-National ZX008 trial principal investigator and KUL University Hospitals childhood epilepsy programme director and paediatric neurology department head Lieven Lagae said: "We are excited to begin this clinical trial, since we view ZX008 as an important potential new treatment option for children and adolescents with Dravet syndrome.
"This is a devastating epilepsy syndrome and a severely under-served patient population. The open-label clinical data generated to date for ZX008 have been compelling and we look forward to conducting this Phase III clinical trial."
Dravet syndrome is a rare and catastrophic form of epilepsy that occurs in infancy and causes severe, long-lasting, fever-related seizures during the initial years with further occurrences of other type of seizures in the following years.
Zogenix's ZX008 is a low-dose fenfluramine liquid to treat patients afflicted with Dravet syndrome, and has been designated as an orphan drug both in the US and Europe.