NCT05757544

Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)

A Study to Optimize the Dosing Regimen and Assess Safety and Efficacy of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to optimize the dosing regimen and evaluate the preliminary safety and efficacy of Intravenous (IV) ganaxolone as adjuvant therapy for participants with ESE receiving initial IV antiepileptic drug (AED) according to currently practiced standard of care (SOC). The study will be composed of 2 phases: an initial, open-label, dose optimization phase followed by IV ganaxolone versus placebo double-blind phase.

Conditions

• Status Epilepticus

Interventions

Type	Name	Description
DRUG	IV Ganaxolone	IV Ganaxolone will be administered.
DRUG	IV Placebo	IV Placebo will be administered

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2023-03-07
• Last updated: 2024-05-07

Regulatory

• FDA-regulated drug study