CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 253 enrolled
Drug / intervention
eslicarbazepine acetate +2 moredrug
Likely dose
eslicarbazepine acetate 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00957372
NCT00957372Phase 3Completed
CompareCT.gov

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

Bial - Portela C S.A.·interventional·Posted Aug 12, 2009·Updated Jul 2, 2014

In Brief

A Phase 3 clinical trial evaluating eslicarbazepine acetate, placebo (Part I), and 1 other intervention for Partial Epilepsy. Completed, enrolled 253 participants across 1 site.

Detailed Summary

The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsy
CountriesPortugal
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 12, 2009
Enrollment StartDec 1, 2004
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.9 years ago

Interventions

eslicarbazepine acetatedrug

oral tablet, 800 mg or 1200 mg once daily

placebo (Part I)drug

once daily placebo comparator

ESL - Open-label Extension (Part II)drug

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