Conditions: Refractory Partial Onset Seizures
Keywords: Refractory Partial Onset Seizures, epilepsy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 286
Healthy volunteers: no

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:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Rufinamide
Intervention descriptions: intervention 1: Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

Protocol document: