Randomized Therapy In Status Epilepticus — RAISE  

Status Epilepticus Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

This study will evaluate the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

Clinical Trial Description

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 following failure of any two or more antiseizure medications (benzodiazepine and one IV antiepileptic drug (AED) or two IV AEDs. Participants will be screened for inclusion/exclusion criteria prior to receiving investigational product by continuous IV infusion. Participants will be followed for approximately 4 weeks. Participants who are known to be at risk for SE may be consented or assented prior to an SE event. ;

Related Conditions & MeSH terms

• Status Epilepticus

• NCT number: NCT04391569
• Study type: Interventional
• Source: Marinus Pharmaceuticals
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 10, 2020
• Completion date: November 30, 2024