NCT00957047

Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy

Efficacy and Safety of BIA 2-093 as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period. Patients who complete Part I may enter a 1-year open-label extension.

Detailed description

Part I was a 22-week parallel-group, randomized, placebo-controlled period (8 weeks baseline, 2 weeks double-blind titration, and 12 weeks maintenance). After completing the baseline period, patients were randomized in a 1:1:1:1 ratio to 1 of the 3 ESL dose levels or to placebo. Part II was a 1-year open-label extension for patients who had completed Part I. The starting dose was 800 mg once daily and could be titrated up or down at 400-mg intervals between 400 and 1200 mg.

Conditions

• Partial Epilepsy

Interventions

Type	Name	Description
DRUG	eslicarbazepine acetate	oral tablets
DRUG	placebo	once daily placebo comparator
DRUG	ESL - Part II	Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.

Timeline

• Start date: 2004-07-01
• Primary completion: 2006-08-01
• Completion: 2008-01-01
• First posted: 2009-08-12
• Last updated: 2025-03-25
• Results posted: 2013-08-05

Locations

1 site across 1 country: Portugal