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

PHASE3CompletedINTERVENTIONAL
Enrollment

306

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

January 31, 2008

Study Completion Date

January 31, 2008

Conditions
Seizures
Interventions
DRUG

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

DRUG

Placebo

Oral tablet.

Trial Locations (54)

5000

Fundacion Lennox, Córdoba

Sanatorio del Salvador II, Córdoba

10003

Beth Israel Medical Center, New York

14050

Hospital de Psiquiatria San Fernando, IMSS, Mexico City

CIF BIOTEC, Medica Sur, Tlalpan

17033

Milton S. Hershey Medical Center, Hershey

19104

Hospital of the University of Pennsylvania, Philadelphia

20817

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

22903

University of Virginia Comprehensive Epilepsy Program, Charlottesville

23298

Virginia Commonwealth University Medical Center, Richmond

28801

Asheville Neurology Specialists, Asheville

32209

University of Florida -- Shands Jacksonville, Jacksonville

33136

University of Miami, Miami

34233

Lovelace Scientific Resources, Sarasota

35294

University of Alabama -- Department of Neurology/Epilepsy Center, Birmingham

35476

Neurology Clinic, Northport

35801

North Alabama Neuroscience Research Associates, Huntsville

37208

Meharry Medical College, Nashville

37212

Vanderbilt University Medical Center, Nashville

40536

University of Kentucky, Lexington

42690

Instituto Nacional de Neurologia y Neurocirugia, La Fama

43614

Medical University of Ohio at Toledo, Toledo

44280

Antiguo Hospital Civil de Guadalajara, Guadalajara

48202

Henry Ford Hospital, Detroit

50010

McFarland Clinic, Ames

55102

Minnesota Epilepsy Group, P.A., Saint Paul

63017

The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield

64000

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

72205

Clinical Trials Inc., Little Rock

75230

Medical City Dallas Hospital, Dallas

Neurological Clinic of Texas, Dallas

77030

Memorial Hermann Hospital, Houston

78250

Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosí City

80010

University of Colorado Health Science Center, Denver

80918

Delta Waves, Colorado Springs

85013

Barrow Neurological Institute, Phoenix

90033

University of Southern California, Los Angeles

90073

West Los Angeles VA Healthcare Center, Los Angeles

92037

UCSD Thornton Hospital, La Jolla

97062

Oregon Neurology PC, Tualatin

C1181ACH

Hospital Italiano de Buenos Aires, Capital Federal

C1221ADC

"Hospital General de Agudos Dr. J.M. Ramos Mejia", Capital Federal

C1406FWY

"Hospital General de Agudos Dr. Teodoro Alvarez", Capital Federal

X5016KEH

Hospital Privado Centro Medico de Cordoba, Córdoba

40110-060

Hospital Universitario Prof Edgard Santos -- UFBA, Salvador

14048-900

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

04024 002

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

05403-900

Hospital das Clinicas da Fac de Medicina de Sao Paulo, São Paulo

T2N 2T9

Foothills Medical Center, Calgary

T5G 0B7

Glenrose Rehabilitation Center, Edmonton

A1B 3V6

Health Sciences Centre, St. John's

H2L 4M1

CHUM -- Hôpital Notre-Dame, Montreal

03229

Centro Medico, Mexico City

Unknown

instituto Nacional de Neurologia y Neurocirugia, Mexico City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Bausch Health Americas, Inc.

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY