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

NCT ID: NCT00232596

Last Updated: 2016-12-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Seizures

Keywords

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Partial Seizures Anticonvulsant Complex Partial Seizures Potassium Channels Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral tablet.

Retigabine

Group Type EXPERIMENTAL

Retigabine

Intervention Type DRUG

Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase

Interventions

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Retigabine

Oral tablet. The starting daily dose will be 300 mg/day administered orally in three equally divided doses. This dosage will be increased by 150 mg/day (50 mg/dose) at 1-week intervals (titration phase). At the beginning of Week 7, patients will enter a 12 week maintenance phase

Intervention Type DRUG

Placebo

Oral tablet.

Intervention Type DRUG

Other Intervention Names

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D-23129 GKE-841

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of refractory epilepsy with simple or complex partial onset seizures with or without secondary generalization
* 28-day partial seizure frequency rate of four or more partial seizures over the 8-week baseline phase
* Currently treated with up to three established AEDs
* Vagal Nerve Stimulator may be included

Exclusion Criteria

* Existing medical or psychiatric condition which could affect patient's health or compromise ability to participate in the study
* Clinically significant abnormalities on physical exam, vital signs, ECG, or liver function 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 study entry
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role collaborator

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

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 Health Science Center

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

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Meharry Medical College

Nashville, Tennessee, 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

instituto Nacional de Neurologia y Neurocirugia

Mexico City, , Mexico

Site Status

Countries

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United States Argentina Brazil Canada Mexico

References

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Porter RJ, Burdette DE, Gil-Nagel A, Hall ST, White R, Shaikh S, DeRossett SE. Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials. Epilepsy Res. 2012 Aug;101(1-2):103-12. doi: 10.1016/j.eplepsyres.2012.03.010. Epub 2012 Apr 16.

Reference Type DERIVED
PMID: 22512894 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Study Protocol

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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VRX-RET-E22-301

Identifier Type: -

Identifier Source: org_study_id