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13 June 2016

Phase 3 clinical trial announced for Dravet Syndrome drug

The second Phase 3 clinical trial is to begin for ZX008, a branded version of low-dose fenfluramine, designed as an adjunctive treatment of seizures in children with Dravet syndrome.

Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy is a rare, severe and therapy-resistant form of epilepsy most often caused by an identifiable gene defect.

Dravet Syndrome

Children with Dravet syndrome experience severe, long-lasting, fever-related seizures in the first year of life. Other seizures typically arise later, often resulting in severe cognitive and developmental impairment.

“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,” said Lieven Lagae, M.D., Ph.D., principal investigator of the multi-national ZX008 trial.

'Under-served patient population'

“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 3 clinical trial.”

The trial

The trial is randomised and ‘double-blinded’ and will test the safety and efficacy of two different doses of ZX008, compared with a placebo.

Zogenix is currently running the first phase of the study across North America, and aims to recruit 105 subjects for the study in western Europe and Australia.

Both trials will assess the frequency of convulsive seizures in participants taking ZX008 and compare this with seizure frequency seen in people taking placebo.

Comment by Epilepsy Society's Professor Ley Sander

Epilepsy Society’s medical director, Professor Ley Sander said: 'Dravet syndrome is a devastating condition involving many seizures, often on a daily basis. Any potential drug that may reduce seizure activity and offer better quality of life, must bring hope to parents of children with this form of treatment resistant epilepsy.'


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