Open-label Extension Study of the Phase 3 VRX-RET-E22-301 Double-Blind Trial

• Status: Completed
• Trial end date: 2017-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ezogabine

Criteria

Inclusion Criteria:

• Patient has successfully completed the Maintenance and Transition phases of Study VRX-RET-E22-301 for the treatment of partial-onset seizures

• Patient is expected to benefit from participation in the study in the opinion of the Investigator.

Exclusion Criteria:

• Patient meets any of the withdrawal criteria in the previous VRX-RET-E22-301 study or is experiencing an ongoing serious adverse event.

• Patient is receiving any investigational drug or using any experimental device in addition to Retigabine for treatment of epilepsy or any other medical condition.

• Patient has any other condition that would prevent compliance with the study procedures or proper reporting of adverse events.