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RAndomized Therapy In Status Epilepticus (RAISE)

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ClinicalTrials.gov Identifier: NCT04391569
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Marinus Pharmaceuticals

Study Description
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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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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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


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04391569


Contacts
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Contact: Maciej Gasior, MD, PhD 484-639-4875 mgasior@marinuspharma.com
Contact: Heather Van Heusen, M Ed 484-802-2470 hvanheusen@marinuspharma.com

Locations
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Sponsors and Collaborators
Marinus Pharmaceuticals
Investigators
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Study Director: Maciej Gasior, MD, PhD Marinus Pharmaceuticals, Inc.
More Information
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Responsible Party: Marinus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04391569    
Other Study ID Numbers: 1042-SE-3003
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 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:
seizure
Additional relevant MeSH terms:
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Status Epilepticus
Nervous System Diseases
Seizures
Neurologic Manifestations