Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)
Status:
Not yet recruiting
Trial end date:
2026-02-01
Target enrollment:
Participant gender:
Summary
This study is designed to optimize the dosing regimen and evaluate the preliminary safety and
efficacy of Intravenous (IV) ganaxolone as adjuvant therapy for ESE receiving initial IV
antiepileptic drug (AED) according to currently practiced standard of care (SOC). The study
will be composed of 2 phases: an initial, open-label, dose optimization phase followed by IV
ganaxolone versus placebo double-blind phase.