Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus



Status:Recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:12 - Any
Updated:9/30/2018
Start Date:February 19, 2018
End Date:December 2019
Contact:Heather Van Heusen, M.Ed.
Email:hvanheusen@marinuspharma.com
Phone:484-801-4682

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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.

Inclusion Criteria:

- Subjects 12 years of age and older

- Clinical and/or electrographic seizures

Exclusion Criteria:

- 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
We found this trial at
4
sites
Durham, North Carolina 27708
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Miami, Florida 33155
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New Orleans, Louisiana 70121
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