At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 395 enrolled
Drug / intervention
eslicarbazepine acetate +2 moredrug
Likely dose
Not stated in 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.
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
In Brief
A Phase 3 clinical trial evaluating eslicarbazepine acetate, placebo, and 1 other intervention for Partial Epilepsy. Completed, enrolled 395 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsy
CountriesPortugal
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
Primary CompletionAug 2006
Study CompletionJan 2008
First PostedAug 2009
TodayJul 2026
First PostedAug 12, 2009
Enrollment StartJul 1, 2004
Primary CompletionAug 1, 2006
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.9 years ago
Interventions
eslicarbazepine acetatedrug
oral tablets
placebodrug
once daily placebo comparator
ESL - Part IIdrug
Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.