RAndomized Therapy In Status Epilepticus

Purpose

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

Conditions

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

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • clinical and/or electrographic seizures

Exclusion Criteria

  • 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
IV Placebo
Placebo bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
  • Drug: Placebo
    Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.
Experimental
IV ganaxolone active
Ganaxolone bolus dose followed by continuous infusion for 36 hours, followed by 12 hour taper
  • Drug: Ganaxolone
    Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.

Recruiting Locations

Marinus Research Site
Birmingham, Alabama 35017

Marinus Research Site
Downey, California 90242

Marinus Research Site
Orange, California 92868

Marinus Research Site
San Diego, California 92037

Marinus Research Site
Aurora, Colorado 80045

Marinus Research Site
New Haven, Connecticut 06520

Marinus Research Site
Jacksonville, Florida 32224

Marinus Research Site
Urbana, Illinois 61801

Marinus Research Site
Baltimore, Maryland 21215

Marinus Research Site
Boston, Massachusetts 02111

Marinus Research Site
Grand Rapids, Michigan 49503

Marinus Research Site
Rochester, Minnesota 55905

Marinus Research Site
Saint Louis, Missouri 63110

Marinus Research Site
New York, New York 10075

Marinus Research Site
Rochester, New York 14642

Marinus Research Site
Winston-Salem, North Carolina 27103

Marinus Research Site
Cincinnati, Ohio 45267

Marinus Research Site
Portland, Oregon 97239

Marinus Research Site
Philadelphia, Pennsylvania 19104

Marinus Research Site
Pittsburgh, Pennsylvania 15212

Marinus Research Site
Knoxville, Tennessee 37920

Marinus Research Site
Galveston, Texas 77555

More Details

NCT ID
NCT04391569
Status
Recruiting
Sponsor
Marinus Pharmaceuticals

Study Contact

Maciej Gasior, MD, PhD
484-639-4875
mgasior@marinuspharma.com

Detailed 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 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.