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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Epilepsy

Treatments

Drug: Ezogabine: USAN Retigabine (International Nonproprietary Name)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00310375

RTG115098 (Other Identifier)

VRX-RET-E22-303

Details and patient eligibility

About

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.

Full description

This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Enrollment

181 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.