RAndomized Therapy In Status Epilepticus
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 168
Summary
- Conditions
- Convulsive Status EPILEPTICUS
- Epilepsy
- Non Convulsive Status Epilepticus
- Status Epilepticus
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
This is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of IV ganaxolone in status epilepticus. Investigational product will be added to standard of care before IV anesthetic during the treatment of SE. Subjects will be screened for inclusion/exclusion criter...
This is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of IV ganaxolone in status epilepticus. Investigational product 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 investigational product by continuous IV infusion. Subjects will be followed for approximately 4 weeks. Subjects who are known to be at risk for SE may be consented or assented prior to an SE event.
Tracking Information
- NCT #
- NCT04391569
- Collaborators
- Not Provided
- Investigators
- Study Director: Maciej Gasior, MD, PhD Marinus Pharmaceuticals, Inc.
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