Status:
COMPLETED
Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus
Lead Sponsor:
Marinus Pharmaceuticals
Conditions:
Status Epilepticus
Convulsive Status EPILEPTICUS
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- Subjects 12 years of age and older
- Clinical and/or electrographic seizures
Exclusion
- 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
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03350035
Start Date
February 19 2018
End Date
September 18 2019
Last Update
March 9 2023
Active Locations (8)
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1
Nemours/AI duPont Hospital for Children
Wilmington, Delaware, United States, 19803
2
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
3
Grady Hospital
Atlanta, Georgia, United States, 30303
4
Oschner Clinic Foundation
New Orleans, Louisiana, United States, 70121