Overview

This trial is active, not recruiting.

Condition epilepsy
Treatment ezogabine: usan retigabine: inn
Phase phase 3
Sponsor GlaxoSmithKline
Start date May 2006
End date December 2015
Trial size 181 participants
Trial identifier NCT00310375, RTG115098, VRX-RET-E22-303

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Film-coated tablets - 50mg, 100mg or 300mg
ezogabine: usan retigabine: inn GKE-841
Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.

Primary Outcomes

Measure
Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase.
time frame: Frequency rates to be determined at end of the open-label treatment phase

Secondary Outcomes

Measure
Reports of adverse events
time frame: At selected study visits
Results of vital signs
time frame: At selected study visits
Weight
time frame: At selected study visits
Clinical laboratory evaluations
time frame: At selected study visits
12-lead ECG
time frame: At selected study visits
Post-void residual bladder ultrasounds
time frame: At selected study visits

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title A Multicenter, Open-label, Long-term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-onset Seizures (Extension of Study VRX-RET-E22-301)
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.