356
Participants
Start Date
February 13, 2006
Primary Completion Date
May 20, 2009
Study Completion Date
May 20, 2009
Placebo
For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo tablet every 3 days up to maximum of 4 matching placebo tablets twice daily (placebo tablet matched to rufinamide total daily dose of 3200 mg). For the 12 week maintenance phase, 4 placebo tablets matching to rufinamide maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Similar to the dose reduction permitted in the rufinamide group, participants in placebo group will be allowed only during the Titration Phase to have the dose reduced to 3 placebo tablets twice daily.
Rufinamide
For the titration phase, Rufinamide will be administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) will be administered. Participants unable to tolerate the target dose (3200 mg/day) will be allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
New York University Medical Centre, Comprehensive Epilepsy Center, New York
Weill Cornell Medical Center, Comprehensive Epilepsy Center, New York
Columbia University Medical Center, New York
Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx
Five Towns Neuroscience Research, Lawrence
University of Rochester Medical Center, Rochester
Blair Medical Associates, Inc., Altoona
The Children's Hospital of Philadelphia, Philadelphia
Georgetown University Hospital, Dept. of Neurology, Washington D.C.
Children's National Medical Center, Washington D.C.
John Hopkins Hospital, Dept. of Neurology, Baltimore
Duke Health Center at Morreene Road, Durham
Asheville Neurology Specialists, PA, Asheville
Medical Associates of North Georgia, Canton
Child Neurology Associates, PC, Atlanta
Medical College of Georgia, Dept. of Neurology, Augusta
University of Florida, The Neuroscience Institute at Shands, Jacksonville
Bay Medical Center, Panama City
University of Florida, Dept. of Neurology, Gainesville
Nemours Children's Clinic, Orlando
Pediatric Neurologists of Palm Beach, Loxahatchee Groves
University of Southern Florida, Dept. of Neurology, Tampa
Bradenton Research Center, Bradenton
Neurology Clinic PC, Northport
University of South Alabama Medical Center, Mobile
Access Clinical Trials, Inc, Nashville
University of Tennessee Health Sciences Center, Dept. of Neurology, Memphis
Mid-South Physicians Group, PLLC, Germantown
Ronald Schwartz, M.D., Hattiesburg
Ohio State University, Columbus
Medical University of Ohio at Toledo, Dept. of Neurology, Toledo
Cleveland Clinic Foundation, Dept. of Neurology, Cleveland
Mcfarland Clinic, Ames
University of Wisconsin, Dept. of Neurology, Madison
Minnesota Epilepsy Group, PC, Saint Paul
University of Minnesota, Dept. of Neurology, Minneapolis
Advocate Lutheran General Children's Hospital, Park Ridge
Advocate Hope Children's Hospital, Oak Lawn
The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield
Saint Louis University, St Louis
Washington University, St Louis
Saint John's Medical Research, Springfield
Via Christi Comprehensive Epilepsy Center, Wichita
Clinical Trials, Inc, Little Rock
University of Oklahoma Health Sciences Center, Oklahoma City
Baylor Medical Center of Irving, Irving
Neurological Clinic of Texas, PA, Dallas
Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry, El Paso
Epilepsy and Neurodevelopment, Inc., West Jordan
Barrow Neurological Institute, Phoenix
Mayo Clinic Epilepsy and Neurology, Phoenix
Neurology Center, Oceanside
Neuro-Pain Medical Center, Inc., Fresno
California Pacific Epilepsy, San Francisco
The Queen's Medical Center, Honolulu
University of Washington, Harborview Medical Center, Regional Epilepsy Center, Seattle
University of Arizona, Dept. of Neurology, Tucson
Pediatric Neurology - PA, Orlando
Hattiesburg Clinic, Hattiesburg
Children's Hospital of Pittsburgh - Dept of Pediatrics, Pittsburgh
UT Medical Group, Memphis
University of Texas - Dept of Neurology, Houston
Fletcher Allen Healthcare, Burlington
Children's Memorial Hospital, Northwest University, Chicago
Southern Illinois University Neurology and Pharmacology, Springfield
University of Kentucky, Dept. of Neurology, Lexington
Children's Hospital Boston, Boston
Boston University Medical Center, Dept. of Neurology, Boston
University of Massachusetts, Neurology Associates, Hopedale
Dartmouth Medical School Neuroscience Center, Lebanon
University of North Carolina at Chapel Hill, Dept. of Neurology, Chapel Hill
Hospital of The University of Pennsylvania, Philadelphia
Hospital of the University of Pennsylvania, Dept. of Neurology, Philadelphia
Rhode Island Hospital, Providence
University of Texas Southwestern Medical Center at Dallas, Dallas
University of Vermont, College of Medicine, Clinical Neurophysiology Lab, Burlington
Virginia Commonwealth University, Richmond
Eisai Inc.
INDUSTRY