clinical trial · NCT05757544
Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)
Status EpilepticusIV GanaxoloneIV Placebo
brief 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 participants with 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.
started
Apr 1, 2023
primary completion
Feb 1, 2026
completion
Feb 1, 2026
last updated
May 7, 2024
official title
A Study to Optimize the Dosing Regimen and Assess Safety and Efficacy of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol