Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

December 31, 2004

Primary Completion Date

June 30, 2008

Study Completion Date

June 30, 2008

Conditions
Partial Epilepsy
Interventions
DRUG

eslicarbazepine acetate

oral tablet, 800 mg or 1200 mg once daily

DRUG

placebo (Part I)

once daily placebo comparator

DRUG

ESL - Open-label Extension (Part II)

Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day

Trial Locations (1)

4745-457

Bial - Portela & Cª, S.A., S. Mamede Do Coronado

All Listed Sponsors
lead

Bial - Portela C S.A.

INDUSTRY

NCT00957372 - Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy | Biotech Hunter | Biotech Hunter