A Multicenter Randomized Double-blind Parallel Group Placebo-controlled Trial of Two Fixed Doses of ZX008 Oral Solution as Adjunctive Therapy for Seizures in Children and Adults with LGS

Brief description of study

The main purpose of this study is to learn if and how well the study drug works and if the study drug is safe and tolerable compared to placebo in children and adults with Lennox-Gastaut Syndrome (LGS). A placebo is an inactive material that looks like the study drug but does not contain any active study drug. This study will also measure how much of the study drug ZX008 is in the blood. The study drug, ZX008, or placebo, will be added to your regular epilepsy medications that your doctor has prescribed. The main purpose of Part 2 of this study is to learn about the long-term safety and tolerability (the impact of the study drug on your body and how well you tolerate it) of the study drug (ZX008) given for 12 months. The study will also see how well the study drug works in decreasing the frequency of seizures in children and young adults with LGS who participated in Part 1 of the study. In the open-label extension ZX008 will be added to your regular epilepsy medications that your doctor has prescribed.


Clinical Study Identifier: s17-01303
ClinicalTrials.gov Identifier: NCTs17-01303


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