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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
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.
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.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Nemours/AI duPont Hospital for Children
Wilmington, Delaware, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Grady Hospital
Atlanta, Georgia, United States
Oschner Clinic Foundation
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Duke Medical Center
Durham, North Carolina, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Start Date
February 19, 2018
Primary Completion Date
September 18, 2019
Completion Date
September 18, 2019
Last Updated
March 9, 2023
17
ACTUAL participants
IV Ganaxolone active
DRUG
IV Placebo, non-active
DRUG
Lead Sponsor
Marinus Pharmaceuticals
NCT05140265
NCT06100978
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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