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Ganaxolone in status epilepticus


Title A double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous Ganaxolone in status epilepticus
Therapeutic Area Status Epilepticus
Principal Investigator Josh Kornbluth, MD
Min Age 18 Years
Gender All
Contact Pradnya Ghule
617 636-7620
pghule@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04391569

Overview

Status Epilepticus(SE) is a serious condition that needs fast treatment to stop the seizures and prevent permanent brain damage. The purpose of this research is to find out if ganaxolone can stop or decrease the seizure activity in participants who have SE and if ganaxolone is safe compared to placebo when given to participants who are on other anti-seizure medications.

Study Details

Inclusion Criteria

  • Convulsive or nonconvulsive SE without a pattern of improvement and at least 15 minutes of continuous or cumulative, intermittent seizure activity in the 30-minute period immediately prior to IP initiation, and either:
    • Convulsive SE: Clinical seizure activity, or
    • Nonconvulsive SE: Must have an ictal EEG pattern consistent with modified Salzburg criteria17
  • Participants must have received a benzodiazepine and two or more of the following second line AEDs for treatment of the current episode of SE, administered at an adequate dose and duration to demonstrate efficacy, in the opinion of the investigator
  • BMI < 35 or, if BMI is not able to be calculated at screening, participant is assessed by investigator as not morbidly obese

Exclusion Criteria

  • Life expectancy of less than 24 hours
  • Anoxic brain injury or an uncontrolled metabolic condition as the primary cause of SE (e.g., hypoglycemia < 50mg/dL or hyperglycemia > 400 mg/dL)
  • Treatment of the current SE episode with IV anesthetics (e.g., midazolam, propofol, thiopental. pentobarbital/phenobarbital or ketamine) at adequate doses and for an adequate duration to induce anesthesia

Study Requirements

We expect that you will be in this research study for 4 weeks. The investigational drug would be given intravenously to the subject for 2 days. The subject would have weekly follow up visits for 3-4 weeks. Blood samples would be taken 3-4 times. Study specific EEG would be performed