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 : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Status Epilepticus Convulsive Status EPILEPTICUS Non Convulsive Status Epilepticus Epilepsy||Drug: IV Ganaxolone active Drug: IV Placebo, non-active||Phase 2|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|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)|
|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|
Experimental: IV Ganaxolone active
Ganaxolone IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
Drug: IV Ganaxolone active
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: IV Placebo, non-active
- 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
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
|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|
|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|
|Study Director:||Maciej Gasior, MD, PhD||Marinus Pharmaceuticals|