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NCT Number: NCT03350035

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.

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Key information

Conditions

Status Epilepticus Brain Diseases Central Nervous System Diseases Convulsive Status EPILEPTICUS Epilepsy Nervous System Diseases Neurologic Manifestations Non Convulsive Status Epilepticus Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nemours/AI duPont Hospital for Children, Wilmington, Delaware, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV Ganaxolone active

Drug

IV

IV Placebo, non-active

Drug

IV

Primary outcomes

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

    Time frame: 24 hours post study drug initiation

    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.

Secondary outcomes

  1. Time to Cessation of SE

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

    Summary of Time to SE Cessation

  2. 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 who Required No Escalation of Treatment for Ongoing or Recurrent SE

  3. Number of Participants With No SE Recurrence Per Principal Investigator

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

    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.

  4. Seizure Burden

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

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

Sponsors and collaborators

Lead sponsor

Marinus Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2017
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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