Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

Total of all reporting groups

Safety population

Safety population: All participants who received at least 1 dose of study medication.

Race (safety population)

Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase. For participants who immediately entered study 302 after study 301, rufinamide was maintained at dose of 2400 or 3200 mg/day achieved at the end of study 301. Participants with delay between the end of Study 301 and the beginning of Study 302 started rufinamide at a dose of 800 mg/day, and had the dose titrated to the maximum tolerated dose (2400 or 3200 mg/day) over the next 12 to 18 days. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, participants completed a 12-day Transition Phase where they transitioned from placebo to rufinamide at 800 mg/day at the start of transition phase, with subsequent dose increased to 3200 mg/day. During the open-ended open-label Maintenance Phase, changes in the rufinamide dose were permitted for all participants; however, the dose was maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).