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

Condition(s) targeted: Epilepsies, Partial

Intervention: Retigabine (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: Valeant Pharmaceuticals North America

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.

Official title: A Multicenter, Open-Label, Long-Term, Safety, Tolerability and Efficacy Study of Retigabine in Adult Epilepsy Patients With Partial-Onset Seizures (Extension of Study VRX-RET-E22-301)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Percentage change in the monthly seizure rate from the baseline phase to the open-label treatment phase.

Secondary outcome:

Reports of adverse events

Results of vital signs

Weight

Clinical laboratory evaluations

12-lead ECG

Post-void residual bladder ultrasounds

Detailed 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Neurology Clinic, Northport, Alabama 35476, United States

North Alabama Neuroscience Research Associates, Huntsville, Alabama 35801, United States

University of Alabama -- Department of Neurology/Epilepsy Center, Birmingham, Alabama 35294, United States

Foothills Medical Center, Calgary, Alberta T2N 2T9, Canada

Glenrose Rehabilitation Center, Edmonton, Alberta T5G 0B7, Canada

Barrow Neurological Institute, Phoenix, Arizona 85013, United States

Clinical Trials Inc., Little rock, Arkansas 72205, United States

Hospital Universitario Prof Edgard Santos -- UFBA, Salvador, BA 40110-060, Brazil

Hospital Italiano de Buenos Aires, Capital Federal, CBA C1181ACH, Argentina

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

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

Fundacion Lennox, Cordoba, CRD 5000, Argentina

Hospital Privado Centro Medico de Cordoba, Cordoba, CRD X5016KEH, Argentina

Sanatorio del Salvador II, Cordoba, CRD 5000, Argentina

University of Southern California -- Keck School of Medicine, Los Angeles, California 90033, United States

West Los Angeles VA Healthcare Center, Los Angeles, California 90073, United States

UCSD Thornton Hospital, La Jolla, California 92037, United States

Delta Waves, Colorado Springs, Colorado 80918, United States

Centro Medico, Mexico, DF 03229, Mexico

CIF BIOTEC, Medica Sur, Tlalpan, DF 14050, Mexico

Hospital de Psiquiatria San Fernando, IMSS, Mexico, DF 14050, Mexico

Instituto Nacional de Neurologia y Neurocirugia, La Fama, DF 42690, Mexico

Lovelace Scientific Resources, Sarasota, Florida 34233, United States

University of Florida -- Shands Jacksonville, Jacksonville, Florida 32209, United States

University of Miami, Miami, Florida 33136, United States

McFarland Clinic, Ames, Iowa 50010, United States

Antiguo Hospital Civil de Guadalajara, Guadalajara, Jalisco 44280, Mexico

University of Kentucky, Lexington, Kentucky 40536, United States

Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland 20817, United States

Henry Ford Hospital, Detroit, Michigan 48202, United States

Minnesota Epilepsy Group, P.A., St. Paul, Minnesota 55102, United States

The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield, Missouri 63017, United States

Beth Israel Medical Center, New York, New York 10003, United States

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

Asheville Neurology Specialists, Asheville, North Carolina 28801, United States

Hospital y Clinica OCA S.A. de C.V., Monterrey, Nuevo Leon 64000, Mexico

Medical University of Ohio at Toledo, Toledo, Ohio 43614, United States

Oregon Neurology PC, Tualatin, Oregon 97062, United States

Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States

CHUM -- Hôpital Notre-Dame, Montréal, Quebec H2L 4M1, Canada

Hospital Central Dr. Ignacio Morones Prieto, San Luis Potosi, SLP 78250, Mexico

Hospital das Clinicas da Fac de Medicina de Sao Paulo, Sao Paulo, SP 05403-900, Brazil

Hospital das Clinicas de Ribeirao Preto -- Universidade de Sa Neurologia, Ribeirao Preto, SP 14048-900, Brazil

Hospital Sao Paulo -- Escola Paulista de Medicina -- UNIFESP, Sao Paulo, SP 04024 002, Brazil

Vanderbilt University Medical Center, Nashville, Tennessee 37212, United States

Neurological Clinic of Texas, Dallas, Texas 75230, United States

Memorial Hermann Hospital, Houston, Texas 77030, United States

Virginia Commonwealth University Medical Center, Richmond, Virginia 23298, United States

University of Virginia Comprehensive Epilepsy Program, Charlottesville, Virginia 22903, United States

Starting date: May 2006
Last updated: February 29, 2008