NCT01422720

Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.

Detailed description

Multicenter study in approximately 100 elderly patients. The study will follow an open-label design and will consist of 8-week baseline period, followed by a 26-week treatment period and a 4-week follow-up period.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Eslicarbazepine Acetate	ESL tablets (800 mg) QD

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-08-24
• Last updated: 2017-08-07
• Results posted: 2014-07-18

Locations

48 sites across 10 countries: Austria, Bulgaria, Croatia, Czechia, France, Germany, Poland, Portugal, Romania, Spain