Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Marinus Pharmaceuticals17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Status Epilepticus Convulsive Status EPILEPTICUS Non Convulsive Status Epilepticus Epilepsy

Interventions

IV Ganaxolone activeDRUG

IV Placebo, non-activeDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (8)

Nemours/AI duPont Hospital for Children

Wilmington, Delaware, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Grady Hospital

Atlanta, Georgia, United States

Oschner Clinic Foundation

New Orleans, Louisiana, United States

Outcomes

Primary Outcomes

Number of Participants Who Did Not Require an IV Anesthetic Drug for SE Treatment

Number of participants who did not require an intravenous (IV) Anesthetic Drug (a third-line Treatment) for Status Epilepticus (SE) within the first 24 hours after Study Drug Initiation.

Time frame: 24 hours post study drug initiation

Secondary Outcomes

Time to Cessation of SE

Summary of Time to SE Cessation

Time frame: Time to SE Cessation, assessed up to 24 hours

Number of Participants Who Required No Escalation of Treatment for Ongoing or Recurrent SE

Number of participants who Required No Escalation of Treatment for Ongoing or Recurrent SE

Time frame: Drug initiation through follow-up period, up to approximately 4 weeks

Number of Participants With No SE Recurrence Per Principal Investigator

Number of participants with No SE Recurrence per Principal Investigator within 24hrs of starting treatment, during treatment period (excluding taper), during taper, during 24-hr follow-up period, and during follow-up period.

Time frame: Baseline (within 24hrs of treatment) through follow up period, up to approximately 4 weeks.

Seizure Burden

Seizure Burden (%) Baseline and Percentage Change from Baseline by Time Point

Time frame: Baseline (Pre-dose) to <-24hrs (Post Dose)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.