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

NCT ID: NCT00310375

Last Updated: 2020-07-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-01

Study Completion Date

2017-03-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ezogabine: USAN Retigabine (International Nonproprietary Name)

Film-coated tablets - 50mg, 100mg or 300mg

Group Type EXPERIMENTAL

Ezogabine: USAN Retigabine (International Nonproprietary Name)

Intervention Type DRUG

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.

Interventions

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Ezogabine: USAN Retigabine (International Nonproprietary Name)

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.

Intervention Type DRUG

Other Intervention Names

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GKE-841 D-23129 GW582892X

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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University of Alabama -- Department of Neurology/Epilepsy Center

Birmingham, Alabama, United States

Site Status

North Alabama Neuroscience Research Associates

Huntsville, Alabama, United States

Site Status

Neurology Clinic

Northport, Alabama, United States

Site Status

Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Clinical Trials Inc.

Little Rock, Arkansas, United States

Site Status

UCSD Thornton Hospital

La Jolla, California, United States

Site Status

University of Southern California -- Keck School of Medicine

Los Angeles, California, United States

Site Status

West Los Angeles VA Healthcare Center

Los Angeles, California, United States

Site Status

Delta Waves

Colorado Springs, Colorado, United States

Site Status

University of Colorado Department Of Neurology

Denver, Colorado, United States

Site Status

University of Florida -- Shands Jacksonville

Jacksonville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Lovelace Scientific Resources

Sarasota, Florida, United States

Site Status

McFarland Clinic

Ames, Iowa, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Minnesota Epilepsy Group, P.A.

Saint Paul, Minnesota, United States

Site Status

The Comprehensive Epilepsy Care Center for Children and Adults

Chesterfield, Missouri, United States

Site Status

Beth Israel Medical Center

New York, New York, United States

Site Status

Asheville Neurology Specialists

Asheville, North Carolina, United States

Site Status

Medical University of Ohio at Toledo

Toledo, Ohio, United States

Site Status

Oregon Neurology PC

Tualatin, Oregon, United States

Site Status

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Medical City Dallas Hospital

Dallas, Texas, United States

Site Status

Neurological Clinic of Texas

Dallas, Texas, United States

Site Status

Memorial Hermann Hospital

Houston, Texas, United States

Site Status

University of Virginia Comprehensive Epilepsy Program

Charlottesville, Virginia, United States

Site Status

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Hospital Italiano de Buenos Aires

Capital Federal, CBA, Argentina

Site Status

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

Capital Federal, CBA, Argentina

Site Status

Hospital General de Agudos "Dr. Teodoro Alvarez"

Capital Federal, CBA, Argentina

Site Status

Fundacion Lennox

Córdoba, CRD, Argentina

Site Status

Sanatorio del Salvador II

Córdoba, CRD, Argentina

Site Status

Hospital Privado Centro Medico de Cordoba

Córdoba, CRD, Argentina

Site Status

Hospital Universitario Prof Edgard Santos -- UFBA

Salvador, Estado de Bahia, Brazil

Site Status

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

Ribeirão Preto, São Paulo, Brazil

Site Status

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

São Paulo, São Paulo, Brazil

Site Status

Hospital das Clinicas da Fac de Medicina de Sao Paulo

São Paulo, São Paulo, Brazil

Site Status

Foothills Medical Center

Calgary, Alberta, Canada

Site Status

Glenrose Rehabilitation Center

Edmonton, Alberta, Canada

Site Status

Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

CHUM -- Hôpital Notre-Dame

Montreal, Quebec, Canada

Site Status

Antiguo Hospital Civil de Guadalajara

Guadalajara, Jalisco, Mexico

Site Status

Instituto Nacional de Neurologia y Neurocirugia

La Fama, Mexico City, Mexico

Site Status

Centro Medico

Mexico City, Mexico City, Mexico

Site Status

Hospital de Psiquiatria San Fernando, IMSS

Mexico City, Mexico City, Mexico

Site Status

CIF BIOTEC, Medica Sur

Tlalpan, Mexico City, Mexico

Site Status

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

Monterrey, Nuevo León, Mexico

Site Status

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Countries

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United States Argentina Brazil Canada Mexico

Other Identifiers

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RTG115098

Identifier Type: OTHER

Identifier Source: secondary_id

VRX-RET-E22-303

Identifier Type: -

Identifier Source: org_study_id

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