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

Last updated: July 14, 2020
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT00310375
VRX-RET-E22-303
RTG115098
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

Exclusion

Exclusion Criteria:

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

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

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

Study Design

Total Participants: 181
Study Start date:
May 01, 2006
Estimated Completion Date:
March 15, 2017

Study 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.

Connect with a study center

  • Hospital General de Agudos "Dr. J.M. Ramos Mejia"

    Capital Federal, CBA
    Argentina

    Site Not Available

  • Hospital General de Agudos "Dr. Teodoro Alvarez"

    Capital Federal, CBA
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Capital Federal, CBA C1181ACH
    Argentina

    Site Not Available

  • Fundacion Lennox

    Cordoba, CRD 5000
    Argentina

    Site Not Available

  • Hospital Privado Centro Medico de Cordoba

    Cordoba, CRD X5016KEH
    Argentina

    Site Not Available

  • Sanatorio del Salvador II

    Cordoba, CRD 5000
    Argentina

    Site Not Available

  • Hospital Universitario Prof Edgard Santos -- UFBA

    Salvador, BA 40110-060
    Brazil

    Site Not Available

  • Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia

    Ribeirao Preto, SP 14048-900
    Brazil

    Site Not Available

  • Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP

    Sao Paulo, SP 04024 002
    Brazil

    Site Not Available

  • Hospital das Clinicas da Fac de Medicina de Sao Paulo

    Sao Paulo, SP 05403-900
    Brazil

    Site Not Available

  • Foothills Medical Center

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Glenrose Rehabilitation Center

    Edmonton, Alberta T5G 0B7
    Canada

    Site Not Available

  • Health Sciences Centre

    St. John's, Newfoundland and Labrador A1B 3V6
    Canada

    Site Not Available

  • CHUM -- Hôpital Notre-Dame

    Montréal, Quebec H2L 4M1
    Canada

    Site Not Available

  • CHUM -- Hôpital Notre-Dame

    Montréal, Quebec H2L 4M1
    Canada

    Site Not Available

  • Instituto Nacional de Neurologia y Neurocirugia

    La Fama, DF 42690
    Mexico

    Site Not Available

  • Centro Medico

    Mexico, DF 03229
    Mexico

    Site Not Available

  • Hospital de Psiquiatria San Fernando, IMSS

    Mexico, DF 14050
    Mexico

    Site Not Available

  • CIF BIOTEC, Medica Sur

    Tlalpan, DF 14050
    Mexico

    Site Not Available

  • Antiguo Hospital Civil de Guadalajara

    Guadalajara, Jalisco 44280
    Mexico

    Site Not Available

  • Hospital y Clinica OCA S.A. de C.V.

    Monterrey, Nuevo Leon 64000
    Mexico

    Site Not Available

  • Hospital Central Dr. Ignacio Morones Prieto

    San Luis Potosi, SLP 78250
    Mexico

    Site Not Available

  • University of Alabama -- Department of Neurology/Epilepsy Center

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • North Alabama Neuroscience Research Associates

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Neurology Clinic

    Northport, Alabama 35476
    United States

    Site Not Available

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Clinical Trials Inc.

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • UCSD Thornton Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • University of Southern California -- Keck School of Medicine

    Los Angeles, California 90033
    United States

    Site Not Available

  • West Los Angeles VA Healthcare Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • Delta Waves

    Colorado Springs, Colorado 80918
    United States

    Site Not Available

  • University of Colorado Department Of Neurology

    Denver, Colorado 80010
    United States

    Site Not Available

  • University of Florida -- Shands Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Lovelace Scientific Resources

    Sarasota, Florida 34233
    United States

    Site Not Available

  • McFarland Clinic

    Ames, Iowa 50010
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Minnesota Epilepsy Group, P.A.

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

  • Minnesota Epilepsy Group, P.A.

    St. Paul, Minnesota 55102
    United States

    Site Not Available

  • The Comprehensive Epilepsy Care Center for Children and Adults

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • Asheville Neurology Specialists

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Medical University of Ohio at Toledo

    Toledo, Ohio 43614
    United States

    Site Not Available

  • Oregon Neurology PC

    Tualatin, Oregon 97062
    United States

    Site Not Available

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Medical City Dallas Hospital

    Dallas, Texas 75230
    United States

    Site Not Available

  • Neurological Clinic of Texas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Virginia Comprehensive Epilepsy Program

    Charlottesville, Virginia 22903
    United States

    Site Not Available

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia 23298
    United States

    Site Not Available

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