Intravenous Ganaxolone as Adjunctive Therapy to Treat Subjects With Status Epilepticus

• Status: Completed
• Trial end date: 2019-09-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marinus Pharmaceuticals
• Treatments: Ganaxolone; Pregnanolone

Criteria

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