Rufinamide Given as Adjunctive Therapy in Participants With Refractory Partial Seizures

Phase 3

Completed

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).

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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.

Locations (77): University of South Alabama Medical Center
🇺🇸
Mobile, Alabama, United States
Neurology Clinic PC
🇺🇸
Northport, Alabama, United States
Barrow Neurological Institute
🇺🇸
Phoenix, Arizona, United States
Mayo Clinic Epilepsy and Neurology
🇺🇸
Phoenix, Arizona, United States
University of Arizona, Dept. of Neurology
🇺🇸
Tucson, Arizona, 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
California Pacific Epilepsy
🇺🇸
San Francisco, California, United States
Georgetown University Hospital, Dept. of Neurology
🇺🇸
Washington, District of Columbia, United States
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University of South Alabama Medical Center
🇺🇸Mobile, Alabama, United States