Disclaimer: Epilepsy Research UK is completely neutral and is not affiliated with any pharmaceutical company, or any particular drug compound.The pharmaceutical company, Zogenix, has announced the start of a new clinical trial for a drug compound called ZX008, which it has developed for the treatment of Dravet syndrome.About Dravet syndromeDravet syndrome is a rare and severe form of epilepsy that usually begins at approximately six months of age. It is characterised by seizures that are triggered by fever and do not respond to standard antiepileptic drugs (AEDs).Dravet syndrome can cause severe cognitive and developmental impairments and it is associated with a higher risk of sudden unexpected death in epilepsy (SUDEP).More information about Dravet Syndrome can be found here.About the trialThis is a second phase three clinical trial that will test both the safety and efficacy of two different doses of ZX008, compared with an identical-looking placebo. The trial will be randomised and ‘double-blinded’, meaning that neither the clinicians nor the participants will know who is taking the drug and who is taking the placebo.The company aims to recruit 105 subjects for the study in Western Europe and Australia. The first phase three study is currently enrolling participants aged between two and 18 years old, at a number of sites in North America.Both trials will assess the frequency of convulsive seizures in participants taking ZX008 and compare this with seizure frequency seen in people taking placebo.In a press release distributed by Zogenix, Dr Lieven Lagae, Principal Investigator on the trial, said: “We are excited to begin this clinical trial, as 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 three clinical trial.”About ZX008ZX008 is an investigational product candidate for the treatment of Dravet syndrome. It is a low-dose fenfluramine liquid solution that acts as an indirect stimulator of the sympathetic nervous system, which triggers the body’s ‘fight or flight’ response. ZX008 stimulates the release of serotonin, a chemical messenger thought to contribute to feelings of wellbeing and happiness.ZX008 received orphan drug designation (ODD) in the United States and Europe, meaning that it will undergo an accelerated assessment process due to its potential to address an unmet medical need.Author: Dr Özge ÖzkayaClick here for more articles about other treatments for epilepsy.Click here for more articles about epilepsy in children.
2019-10-26T22:49:51+01:00June 10th, 2016|