4 results
The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…
* To assess the long-term safety and tolerability of ZX008.
The primary objective of Part 1 is the primary objective of the entire study.Part 1The primary objective of Part 1 is:* To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in…
- To examine the safety and feasibility (i.e. technical end result) of using OviTex core PGA during VMR - To assess perioperative complications- To assess 90-day morbidity