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Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03350035
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
Marinus Pharmaceuticals

Brief Summary:
This study will evaluate the effectiveness and safety of an investigational drug, IV ganaxolone, as adjunctive therapy to standard of care 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 2

Detailed Description:

This is a double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of adjunctive IV ganaxolone in subjects with SE.

Study drug 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 study drug as adjunctive therapy by continuous IV. Subject's will be followed up for 3 weeks post-treatment.

Subjects who are known to be at risk for SE may be consented and/or assented prior to an SE event.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind study that will randomize subjects to ganaxolone or placebo in a 1:1 ratio as adjunctive therapy to their standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Randomized, Placebo Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Actual Study Start Date : February 19, 2018
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : September 18, 2019


Arm Intervention/treatment
Experimental: IV Ganaxolone active
Ganaxolone IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
Drug: Ganaxolone
IV

Placebo Comparator: IV Placebo, non-active
Placebo IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
Drug: Placebo
IV




Primary Outcome Measures :
  1. Primary Outcome [ Time Frame: 24 hours post study drug initiation ]
    The number of subjects who didn't require IV anesthetic for SE treatment within the first 24 hours after study drug 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
Criteria

Inclusion Criteria:

  • Subjects 12 years of age and older
  • Clinical and/or electrographic seizures

Exclusion Criteria:

  • Life expectancy of less than 24 hours
  • Anoxic brain injury as primary cause of SE
  • Recent (<24 hour) traumatic brain injury as the primary cause of SE
  • Administered anesthesia for the treatment of SE

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): NCT03350035


Locations
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United States, Delaware
Nemours/AI duPont Hospital for Children
Wilmington, Delaware, United States, 19803
United States, Florida
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
United States, Georgia
Grady Hospital
Atlanta, Georgia, United States, 30303
United States, Louisiana
Oschner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Duke Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Marinus Pharmaceuticals
Investigators
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Study Director: Maciej Gasior, MD, PhD Marinus Pharmaceuticals
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Responsible Party: Marinus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03350035    
Other Study ID Numbers: 1042-SE-2001
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Status Epilepticus
Nervous System Diseases
Seizures
Neurologic Manifestations
Signs and Symptoms