NCT02519439

A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures

A follow-on, Two-year Open-label Extension Study of Ganaxolone as add-on Therapy in Adult Patients With Drug-resistant Partial-onset Seizures

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult patients with drug-resistant partial-onset seizures

Detailed description

This study is a 2-year, open-label continuation for those patients benefiting from ganaxolone treatment after completing Protocol 1042-0603.

Conditions

• Drug Resistant Partial Onset Seizure

Interventions

Type	Name	Description
DRUG	ganaxolone	225 mg capsules 450 mg to 900 mg 2x/day

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-08-11
• Last updated: 2023-06-28
• Results posted: 2023-02-14

Locations

5 sites across 1 country: United States