Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Epilepsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350035
• Other study ID #: 1042-SE-2001
• Status: Completed
• Phase: Phase 2
• Start date: February 19, 2018
• Est. completion date: September 18, 2019

Study information

• Verified date: March 2023
• Source: Marinus Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 18, 2019
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Convulsive Status EPILEPTICUS
• Epilepsy
• Non Convulsive Status Epilepticus
• Status Epilepticus

Intervention

Drug:
• IV Ganaxolone active
IV
• IV Placebo, non-active
IV

Locations

Country	Name	City	State
United States	Grady Hospital	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke Medical Center	Durham	North Carolina
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Oschner Clinic Foundation	New Orleans	Louisiana
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Nemours/AI duPont Hospital for Children	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Marinus Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours post study drug initiation
Secondary	Time to Cessation of SE	Summary of Time to SE Cessation	Time to SE Cessation, assessed up to 24 hours
Secondary	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	Drug initiation through follow-up period, up to approximately 4 weeks
Secondary	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.	Baseline (within 24hrs of treatment) through follow up period, up to approximately 4 weeks.
Secondary	Seizure Burden	Seizure Burden (%) Baseline and Percentage Change from Baseline by Time Point	Baseline (Pre-dose) to <-24hrs (Post Dose)