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RAndomized Therapy In Status Epilepticus (RAISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04391569
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : June 8, 2021
Information provided by (Responsible Party):
Marinus Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Status Epilepticus Convulsive Status EPILEPTICUS Non-Convulsive Status Epilepticus Epilepsy Drug: Ganaxolone Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. SE Cessation [ Time Frame: 30 minutes ]
    Proportion of participants with status epilepticus cessation within 30 minutes of IP initiation without medications for the acute treatment of status epilepticus. SE cessation is determined by clinical and EEG findings.

  2. Progression to IV anesthesia [ Time Frame: 36 hours ]
    Proportion of participants with no progression to IV anesthesia for 36 hours following IP initiation

Secondary Outcome Measures :
  1. Progression to IV anesthesia [ Time Frame: 72 hours ]
    No progression to IV anesthesia for 72 hours following IP initiation

  2. SE Cessation [ Time Frame: 48 hours ]
    Time to SE cessation following IP initiation

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04391569

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Contact: Maciej Gasior, MD, PhD 484-639-4875
Contact: Heather Van Heusen, M Ed 484-802-2470

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Sponsors and Collaborators
Marinus Pharmaceuticals
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Study Director: Maciej Gasior, MD, PhD Marinus Pharmaceuticals, Inc.
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Responsible Party: Marinus Pharmaceuticals Identifier: NCT04391569    
Other Study ID Numbers: 1042-SE-3003
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marinus Pharmaceuticals:
Additional relevant MeSH terms:
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Status Epilepticus
Nervous System Diseases
Neurologic Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
GABA Modulators
GABA Agents