drugset / Trial / NCT00448539

Open-Label Extension Study of Rufinamide Given as Adjunctive Therapy in Patients With Refractory Partial Seizures

NCT00448539

Phase 3 Terminated 286 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start
2007-03-15
Primary completion
2010-05-14
Completion
2010-05-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Rufinamide Small molecule 2400 mg
Subject Rufinamide Small molecule 4800 mg

Indications