Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
NCT ID: NCT03350035
Last Updated: 2023-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
17 participants
INTERVENTIONAL
2018-02-19
2019-09-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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IV Ganaxolone active
Ganaxolone IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
IV Ganaxolone active
IV
IV Placebo, non-active
Placebo IV loading dose with continuous infusion (maintenance dose) for 2-4 days followed by an 18-hour taper.
IV Placebo, non-active
IV
Interventions
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IV Ganaxolone active
IV
IV Placebo, non-active
IV
Eligibility Criteria
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Inclusion Criteria
* Clinical and/or electrographic seizures
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Marinus Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Maciej Gasior, MD, PhD
Role: STUDY_DIRECTOR
Marinus Pharmaceuticals
Locations
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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
Countries
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References
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Vaitkevicius H, Ramsay RE, Swisher CB, Husain AM, Aimetti A, Gasior M. Intravenous ganaxolone for the treatment of refractory status epilepticus: Results from an open-label, dose-finding, phase 2 trial. Epilepsia. 2022 Sep;63(9):2381-2391. doi: 10.1111/epi.17343. Epub 2022 Jul 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1042-SE-2001
Identifier Type: -
Identifier Source: org_study_id
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