Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

This study will evaluate the effectiveness and safety of an investigational product, IV ganaxolone, to treat subjects with status epilepticus.

Official Title

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus

Details

This is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of IV ganaxolone in status epilepticus. Investigational product 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 investigational product by continuous IV infusion. Subjects will be followed for approximately 4 weeks. Subjects who are known to be at risk for SE may be consented or assented prior to an SE event.

Keywords

Status Epilepticus Convulsive Status EPILEPTICUS Non-Convulsive Status Epilepticus Epilepsy seizure Ganaxolone

Eligibility

You can join if…

Open to people ages 12 years and up

  • clinical and/or electrographic seizures

You CAN'T join if...

  • life expectancy of less than 24 hours
  • anoxic brain injury or an uncontrolled metabolic condition as primary cause of SE
  • treatment of current SE episode with IV anesthetics

Locations

  • Marinus Research Site not yet accepting patients
    Sacramento California 95816 United States
  • Marinus Research Site not yet accepting patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Marinus Pharmaceuticals
Links
Sign up for this study
ID
NCT04391569
Phase
Phase 3
Study Type
Interventional
Last Updated