clinical trial · NCT05814523
To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)
Refractory Status EpilepticusGanaxolonePlaceboStandard of care
brief summary
This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.
started
Mar 1, 2024
primary completion
Aug 1, 2024
completion
Aug 1, 2024
last updated
May 14, 2024
official title
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol