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

Completed · Phase 3

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT00310375

Run by

GlaxoSmithKline

People needed

181

Starts

2006-05-01

Expected to finish

2017-03-15

Last updated by the study team

2020-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• North Alabama Neuroscience Research Associates — Huntsville, Alabama, United States
• Neurology Clinic — Northport, Alabama, United States
• Barrow Neurological Institute — Phoenix, Arizona, United States
• Clinical Trials Inc. — Little Rock, Arkansas, United States
• UCSD Thornton Hospital — La Jolla, California, United States
• University of Southern California -- Keck School of Medicine — Los Angeles, California, United States
• West Los Angeles VA Healthcare Center — Los Angeles, California, United States
• Delta Waves — Colorado Springs, Colorado, United States
• University of Colorado Department Of Neurology — Denver, Colorado, United States
• University of Florida -- Shands Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Lovelace Scientific Resources — Sarasota, Florida, United States
• McFarland Clinic — Ames, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Minnesota Epilepsy Group, P.A. — Saint Paul, Minnesota, United States
• The Comprehensive Epilepsy Care Center for Children and Adults — Chesterfield, Missouri, United States
• Beth Israel Medical Center — New York, New York, United States
• Asheville Neurology Specialists — Asheville, North Carolina, United States
• Medical University of Ohio at Toledo — Toledo, Ohio, United States
• Oregon Neurology PC — Tualatin, Oregon, United States
• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Alabama -- Department of Neurology/Epilepsy Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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