drugset / Trial / NCT05757544
Safety and Efficacy Study of IV Ganaxolone as Adjuvant Therapy for Established Status Epilepticus (ESE)
RandomizedSequentialTriple-blindTreatment
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.
Timeline
- Start
- 2023-04-01
- Primary completion
- 2026-02
- Completion
- 2026-02
Outcome
Outcome not reported
Stopped (Business): “for business reasons”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganaxolone | Small molecule | — | Intravenous |
Indications
No indication recorded.