Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

Last updated: October 26, 2016
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Epilepsy

Treatment

N/A

Clinical Study ID

NCT00232596
VRX-RET-E22-301
  • Ages 18-75
  • All Genders

Study Summary

This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of refractory epilepsy with simple or complex partial onset seizures with orwithout secondary generalization

  • 28-day partial seizure frequency rate of four or more partial seizures over the 8-weekbaseline phase

  • Currently treated with up to three established AEDs

  • Vagal Nerve Stimulator may be included

Exclusion

Exclusion Criteria:

  • Existing medical or psychiatric condition which could affect patient's health orcompromise ability to participate in the study

  • Clinically significant abnormalities on physical exam, vital signs, ECG, or liverfunction tests

  • Impaired renal function (creatinine clearance less than 50 mL/minute)

  • Evidence of progressive central nervous disease, lesion, or encephalopathy

  • History of primary generalized seizures

  • History of clustering or flurries or status epilepticus within 12 months of studyentry

Study Design

Total Participants: 306
Study Start date:
September 01, 2005
Estimated Completion Date:
January 31, 2008

Study Description

This Phase 3 study is being conducted in North America, Argentina, and Brazil to evaluate the efficacy and safety of retigabine dosed at 1200 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to three established antiepileptic drugs (AEDs). The primary objective is to demonstrate a superior change in total partial seizure frequency for four weeks from baseline to the double-blind period. The proportion of responders (greater than or equal to 50% reduction in total partial seizure frequency for four weeks from baseline to the double-blind period) will also be evaluated.

Connect with a study center

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

    Capital Federal, CBA C1221ADC
    Argentina

    Site Not Available

  • Hospital General de Agudos "Dr. Teodoro Alvarez"

    Capital Federal, CBA C1406FWY
    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

  • instituto Nacional de Neurologia y Neurocirugia

    Mexico, DF,
    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

    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 Health Science Center

    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.

    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

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Meharry Medical College

    Nashville, Tennessee 37208
    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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