NCT00512317

Open-label Extension to Protocol 1042-0600

An Open-label Extension Study to Evaluate the Safety, Tolerability, and Efficacy of Ganaxolone as add-on Therapy in Adult Patients With Epilepsy Consisting of Uncontrolled Partial-onset Seizures.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Marinus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

To allow open-label extension to patients who have completed Protocol 1042-0600.

Detailed description

This is an open-label study evaluating efficacy and safety of ganaxolone treatment in adults with partial onset epilepsy with or without secondary generalizations.

Conditions

• Epilepsies, Partial

Interventions

Type	Name	Description
DRUG	ganaxolone	liquid suspension dosed tid

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-12-01
• Completion: 2013-09-01
• First posted: 2007-08-07
• Last updated: 2023-01-17
• Results posted: 2023-01-17

Locations

25 sites across 1 country: United States