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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

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 22, 2017
Last Update Posted Date December 24, 2019
Actual Study Start Date  ICMJE February 19, 2018
Actual Primary Completion Date September 18, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
SE Cessation [ Time Frame: 24 hours post study drug initiation ]
Control of Status Epilepticus
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Status Epilepticus
  • Convulsive Status EPILEPTICUS
  • Non Convulsive Status Epilepticus
  • Epilepsy
Intervention  ICMJE
  • Drug: Ganaxolone
    IV
  • Drug: Placebo
    IV
Study Arms  ICMJE
  • Experimental: IV Ganaxolone active
    Ganaxolone IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
    Intervention: Drug: Ganaxolone
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2019)
17
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
250
Actual Study Completion Date  ICMJE September 18, 2019
Actual Primary Completion Date September 18, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03350035
Other Study ID Numbers  ICMJE 1042-SE-2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marinus Pharmaceuticals
Study Sponsor  ICMJE Marinus Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maciej Gasior, MD, PhD Marinus Pharmaceuticals
PRS Account Marinus Pharmaceuticals
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP