At a glance
ClinicalIndex Comparison Record- ✓Age 12–80 years
- ✓Partial-onset seizures (with or without secondary generalization) confirmed by EEG and brain imaging (CT/MRI)
- ✓Refractory seizures: non-controlled despite ≥2 different antiepileptic drugs (concurrent or sequential) for ≥2 years
- ✓≥6 seizures during 56-day baseline phase with no 21-day seizure-free periods (simple partial seizures without motor signs excluded)
- ✕Prior exposure to rufinamide
- ✕Generalized epilepsies (absence seizures, myoclonic epilepsies, Lennox-Gastaut syndrome)
- ✕Simple partial seizures only (without motor signs)
- ✕Status epilepticus in past year or uncountable seizure clusters
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Placebo-Controlled, Parallel-Group Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures
In Brief
A Phase 3 clinical trial evaluating Placebo and Rufinamide for Epilepsy. Completed, enrolled 356 participants across 77 sites.
Detailed 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).
Study Details
Timeline
Interventions
For the 12-day Titration Phase, one matching placebo tablet will be administered twice daily and increased by 1 matching placebo 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 placebo tablets twice daily.
For the titration phase, Rufinamide will be administered orally in doses starting with 400 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 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).