Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

Completed · Phase 2 · Has a placebo group

Conditions studied: Status Epilepticus, Convulsive Status EPILEPTICUS, Non Convulsive Status Epilepticus, Epilepsy

In brief

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.

Key facts

Study ID

NCT03350035

Run by

Marinus Pharmaceuticals

People needed

17

Starts

2018-02-19

Expected to finish

2019-09-18

Last updated by the study team

2023-03-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects 12 years of age and older
• Clinical and/or electrographic seizures

You may not qualify if…

• 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

Where it is running

• 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
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Duke Medical Center — Durham, North Carolina, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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