NCT00448539

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Refractory Partial Onset Seizures

Interventions

Type	Name	Description
DRUG	Rufinamide	Dose will be maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).

Timeline

• Start date: 2007-03-15
• Primary completion: 2010-05-14
• Completion: 2010-05-14
• First posted: 2007-03-19
• Last updated: 2019-11-22
• Results posted: 2012-12-10

Locations

27 sites across 1 country: United States