Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures
- Registration Number
- NCT00334958
- Lead Sponsor
- Eisai Inc.
- Brief Summary
To evaluate the effect of rufinamide on total partial seizure frequency in adolescent and adult participants (12 to 80 years, inclusive) with refractory partial onset seizures maintained on a maximum of 3 stable antiepileptic drugs (AEDs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 356
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo For 12-day Titration Phase and 12 week Maintenance Phase, placebo tablets matching to rufinamide 400 mg oral tablets will be administered according to the same regimen scheme as described for rufinamide. For 12-day Titration Phase, 1 matching placebo tablet will be administered twice daily and increased by 1 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 tablets twice daily. Rufinamide Rufinamide For the 12-day Titration Phase, rufinamide will be administered orally in doses starting with 400 milligram (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 12 week 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).
- Primary Outcome Measures
Name Time Method Percentage Change in Total Partial Seizure Frequency Per 28 Days During Maintenance Phase Relative to the Baseline Phase Baseline, Days 13 to 96 Seizure data was collected via patient diary, which was used to record daily seizure count and type. Intent-to-treat (ITT) population: All randomized participants who had baseline Patient Seizure Diary data and had at least completed the titration period.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With 50% or Greater Reduction in Total Partial Seizure Frequency Per 28 Days During the Maintenance Phase Relative to the Baseline Phase Baseline, Days 13 to 96 Seizure data was collected via patient diary, which was used to record daily seizure count and type.
Log10 Transformed Total Partial Seizure Frequency Per 28 Days During the Baseline Phase and Maintenance Phase Days 13 to 96 Total partial seizure frequencies per 28 days during the double-blind Maintenance and Baseline Phases were transformed using logarithms to the base 10 (log10), because it was expected from previous studies that the results would not be normally distributed.
Reduction From Baseline in Total Partial Seizure Frequency Rate (RRATIO) During Maintenance Phase Baseline, Days 13 to 96 RRATIO= 100\*(T-B)/(T+B) where T= total seizure frequency per 28 days during the Maintenance Phase, and B=total seizure frequency per 28 days during the Baseline Phase.
Trial Locations
- Locations (77)
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
Advocate Hope Children's Hospital
🇺🇸Oak Lawn, Illinois, United States
John Hopkins Hospital, Dept. of Neurology
🇺🇸Baltimore, Maryland, United States
The Comprehensive Epilepsy Care Center for Children and Adults
🇺🇸Chesterfield, Missouri, United States
Asheville Neurology Specialists, PA
🇺🇸Asheville, North Carolina, United States
Hospital of the University of Pennsylvania, Dept. of Neurology
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Vermont, College of Medicine, Clinical Neurophysiology Lab
🇺🇸Burlington, Vermont, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Children's Hospital of Pittsburgh - Dept of Pediatrics
🇺🇸Pittsburgh, Pennsylvania, United States
Children's Memorial Hospital, Northwest University
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Foundation, Dept. of Neurology
🇺🇸Cleveland, Ohio, United States
University of Texas - Dept of Neurology
🇺🇸Houston, Texas, United States
University of Washington, Harborview Medical Center, Regional Epilepsy Center
🇺🇸Seattle, Washington, United States
Medical College of Georgia, Dept. of Neurology
🇺🇸Augusta, Georgia, United States
Clinical Trials, Inc
🇺🇸Little Rock, Arkansas, United States
Neuro-Pain Medical Center, Inc.
🇺🇸Fresno, California, United States
Neurology Center
🇺🇸Oceanside, California, United States
Medical Associates of North Georgia
🇺🇸Canton, Georgia, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
New York University Medical Centre, Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Weill Cornell Medical Center, Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
University of Arizona, Dept. of Neurology
🇺🇸Tucson, Arizona, United States
Bay Medical Center
🇺🇸Panama City, Florida, United States
University of Tennessee Health Sciences Center, Dept. of Neurology
🇺🇸Memphis, Tennessee, United States
Five Towns Neuroscience Research
🇺🇸Lawrence, New York, United States
Baylor Medical Center of Irving
🇺🇸Irving, Texas, United States
Blair Medical Associates, Inc.
🇺🇸Altoona, Pennsylvania, United States
Neurological Clinic of Texas, PA
🇺🇸Dallas, Texas, United States
Fletcher Allen Healthcare
🇺🇸Burlington, Vermont, United States
Via Christi Comprehensive Epilepsy Center
🇺🇸Wichita, Kansas, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
University of Minnesota, Dept. of Neurology
🇺🇸Minneapolis, Minnesota, United States
California Pacific Epilepsy
🇺🇸San Francisco, California, United States
Duke Health Center at Morreene Road
🇺🇸Durham, North Carolina, United States
Access Clinical Trials, Inc
🇺🇸Nashville, Tennessee, United States
Mayo Clinic Epilepsy and Neurology
🇺🇸Phoenix, Arizona, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Neurology Clinic PC
🇺🇸Northport, Alabama, United States
Georgetown University Hospital, Dept. of Neurology
🇺🇸Washington, District of Columbia, United States
Pediatric Neurologists of Palm Beach
🇺🇸Loxahatchee Groves, Florida, United States
University of Florida, The Neuroscience Institute at Shands
🇺🇸Jacksonville, Florida, United States
Boston University Medical Center, Dept. of Neurology
🇺🇸Boston, Massachusetts, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Dartmouth Medical School Neuroscience Center
🇺🇸Lebanon, New Hampshire, United States
The Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Mid-South Physicians Group, PLLC
🇺🇸Germantown, Tennessee, United States
UT Medical Group
🇺🇸Memphis, Tennessee, United States
Epilepsy and Neurodevelopment, Inc.
🇺🇸West Jordan, Utah, United States
Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry
🇺🇸El Paso, Texas, United States
Minnesota Epilepsy Group, PC
🇺🇸Saint Paul, Minnesota, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Child Neurology Associates, PC
🇺🇸Atlanta, Georgia, United States
Saint John's Medical Research
🇺🇸Springfield, Missouri, United States
University of Massachusetts, Neurology Associates
🇺🇸Hopedale, Massachusetts, United States
Advocate Lutheran General Children's Hospital
🇺🇸Park Ridge, Illinois, United States
Mcfarland Clinic
🇺🇸Ames, Iowa, United States
Southern Illinois University Neurology and Pharmacology
🇺🇸Springfield, Illinois, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
Ronald Schwartz, M.D.
🇺🇸Hattiesburg, Mississippi, United States
Hospital of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Medical University of Ohio at Toledo, Dept. of Neurology
🇺🇸Toledo, Ohio, United States
Nemours Children's Clinic
🇺🇸Orlando, Florida, United States
Pediatric Neurology - PA
🇺🇸Orlando, Florida, United States
University of Southern Florida, Dept. of Neurology
🇺🇸Tampa, Florida, United States
University of North Carolina at Chapel Hill, Dept. of Neurology
🇺🇸Chapel Hill, North Carolina, United States
University of Florida, Dept. of Neurology
🇺🇸Gainesville, Florida, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
University of Kentucky, Dept. of Neurology
🇺🇸Lexington, Kentucky, United States
Montefiore Medical Center, Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
University of Wisconsin, Dept. of Neurology
🇺🇸Madison, Wisconsin, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States