NCT04391569

Randomized Therapy In Status Epilepticus

A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effectiveness and safety of an investigational product (IP), intravenous (IV) ganaxolone, to treat participants with status epilepticus (SE).

Detailed description

This is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of IV ganaxolone in status epilepticus. Investigational product was added to standard of care following failure of any two or more antiseizure medications (benzodiazepine and one IV antiepileptic drug (AED) or two IV AEDs. Participants were screened for inclusion/exclusion criteria prior to receiving investigational product by continuous IV infusion. Participants were followed for approximately 4 weeks. Participants who are known to be at risk for SE were consented or assented prior to an SE event.

Conditions

• Status Epilepticus

Interventions

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

Timeline

• Start date: 2020-12-09
• Primary completion: 2024-03-30
• Completion: 2024-04-28
• First posted: 2020-05-18
• Last updated: 2025-05-29
• Results posted: 2025-05-29

Locations

74 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study