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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
Percentage Change in Total Partial Seizure Frequency Per 28 Days Relative to the Baseline Phase
Seizure data was collected via patient diaries. "OL" refers to "open-label."
Time frame: Baseline, Titration Phase (Days 1 to 18), Maintenance Phase
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of South Alabama Medical Center
Mobile, Alabama, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 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
Pediatric Neurosciences, PA
Orlando, Florida, United States
Bay Medical Center
Panama City, Florida, United States
Child Neurology Associates, PC
Atlanta, Georgia, United States
Southern Illinois University Neurology and Pharmacology
Springfield, Illinois, United States
McFarland Clinic PC
Ames, Iowa, United States
...and 17 more locations