Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Epilepsy Clinical Trial

Official title: A Double-Blind Randomized, Placebo Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Status Completed

Clinical Trial Summary

This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care to treat subjects with status epilepticus.

Clinical Trial Description

This is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of adjunctive IV ganaxolone in subjects with SE.

Study drug will be added to standard of care before IV anesthetic during the treatment of SE.

Subjects will be screened for inclusion/exclusion criteria prior to receiving study drug as adjunctive therapy by continuous IV. Subject's will be followed up for 3 weeks post-treatment.

Subjects who are known to be at risk for SE may be consented and/or assented prior to an SE event. ;

Related Conditions & MeSH terms

• Convulsive Status EPILEPTICUS
• Epilepsy
• Non Convulsive Status Epilepticus
• Status Epilepticus

• NCT number: NCT03350035
• Study type: Interventional
• Source: Marinus Pharmaceuticals
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2018
• Completion date: September 18, 2019