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A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus

Study category: Brain and Nervous System

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Description

Status Epilepticus is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. Ganaxolone is an investigational drug, which means that it is not approved by the US FDA. The study drug will be added on to the usual care patients will already be receiving for their SE. Patients are considered eligible if their seizures do not initially respond to initial prescribed treatments. After consenting to participation, subjects will be randomly selected to either receive ganaxolone or placebo. Also, blood and urine samples will be collected for research. Study participation will last for about 4 weeks, including follow up visits.

Details
Age

Child to Adult

Eligibility

Status epilepticus (non-stop seizures), requiring hospitalization, that last at least 6 minutes or that stop and start but last at least 6 minutes.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
David Case

David Case

Study ID

Protocol Number: 20-1641

More information available at ClinicalTrials.gov: NCT04391569

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