NCT05814523

To Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ganaxolone Added to Standard of Care in Refractory Status Epilepticus (RSE)

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, randomized, placebo-controlled study that will evaluate the efficacy, safety, and tolerability of intravenous (IV) ganaxolone versus placebo co-administered with IV antiepileptic drug (AED) according to standard of care for the treatment of RSE. Approximately 70 participants will be randomized in a 1:1 ratio to receive ganaxolone IV solution or placebo IV solution along with standard of care (SOC) IV AED.

Conditions

• Refractory Status Epilepticus

Interventions

Type	Name	Description
DRUG	Ganaxolone	Ganaxolone will be administered as IV solution.
DRUG	Placebo	Placebo will be administered as IV solution.
DRUG	Standard of care	A non-anesthetic medication not previously used for treatment of SE within the current episode and will be administered at a dose sufficient for the termination of SE according to investigator judgment.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-04-18
• Last updated: 2024-05-14

Locations

52 sites across 16 countries: Austria, Belgium, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Lithuania, Poland, Slovakia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study