[Translation] A randomized, double-blind, placebo-controlled, phase III trial evaluating Ganaxolone (GNX) as add-on therapy in children and adults with tuberous sclerosis syndrome (TSC)-associated epilepsy (TrustTSC)
主要目的:根据双盲期间可计数的主要终点癫痫发作b频率相对于基线a的变化,评估GNX相较于安慰剂作为TSC相关癫痫发作的添加治疗在儿童和成人中的安全性和有效性。
[Translation] PRIMARY OBJECTIVE: To assess the safety and efficacy of GNX compared to placebo as an add-on treatment for TSC-associated seizures in children and adults, based on the enumerable primary endpoint, seizure b frequency, from baseline a during the double-blind period.