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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

"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."

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."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.