Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
- Registration Number
- NCT00448539
- Lead Sponsor
- Eisai Inc.
- Brief Summary
This was an open-label extension study in adolescent and adult (between 12 and 80 years old) participants who had completed their participation in Study E2080-A001-301. The main objective of this study was to evaluate the safety and efficacy of long-term administration of rufinamide for the control of epileptic seizures in participants who had refractory partial seizures despite treatment with a maximum of three approved antiepileptic drugs (AEDs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 286
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rufinamide (Rufinamide During Core Study) Rufinamide - Rufinamide (Placebo During Core Study) Rufinamide -
- Primary Outcome Measures
Name Time Method Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase Baseline, Titration Phase (Days 1 to 18), Maintenance Phase Seizure data was collected via patient diaries. "OL" refers to "open-label."
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Comprehensive Epilepsy Care Center for Children and Adults
🇺🇸Chesterfield, Missouri, United States
Child Neurology Associates, PC
🇺🇸Atlanta, Georgia, United States
John Hopkins Hospital, Dept. of Neurology
🇺🇸Baltimore, Maryland, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
Texas Tech University Health Sciences Center, Dept. of Neuropsychiatry
🇺🇸El Paso, Texas, United States
University of Tennessee Health Sciences Center, Dept. of Neurology
🇺🇸Memphis, Tennessee, United States
McFarland Clinic PC
🇺🇸Ames, Iowa, United States
Hospital of The University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Neurological Clinic of Texas, P.A.
🇺🇸Dallas, Texas, United States
Fletcher Allen Healthcare
🇺🇸Burlington, Vermont, United States
Medical University of Ohio at Toledo - Dept. of Neurology
🇺🇸Toledo, Ohio, United States
University of Pennsylvania Medical Center-Department of Neurology
🇺🇸Philadelphia, Pennsylvania, United States
Five Towns Neuroscience Research
🇺🇸Cedarhurst, New York, United States
University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
Bradenton Research Center
🇺🇸Bradenton, Florida, United States
University of Florida, The Neuroscience Institute at Shands
🇺🇸Jacksonville, Florida, United States
Pediatric Neurologists of Palm Beach
🇺🇸Loxahatchee Groves, Florida, United States
Southern Illinois University Neurology and Pharmacology
🇺🇸Springfield, Illinois, United States
Bay Medical Center
🇺🇸Panama City, Florida, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Asheville Neurology Specialists
🇺🇸Asheville, North Carolina, United States
Dartmouth Medical School Neuroscience Center
🇺🇸Lebanon, New Hampshire, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Weill Cornell Medical Center, Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
New York University Medical Centre, Comprehensive Epilepsy Center
🇺🇸New York, New York, United States
Pediatric Neurosciences, PA
🇺🇸Orlando, Florida, United States
Access Clinical Trials, Inc
🇺🇸Nashville, Tennessee, United States