At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 653 enrolled
Drug / intervention
800 mg QD Eslicarbazepine acetate +2 moredrug
Likely dose
800 mg QD Eslicarbazepine acetatefrom 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 Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Trial
In Brief
A Phase 3 clinical trial evaluating 800 mg QD Eslicarbazepine acetate, 1200 mg QD Eslicarbazepine acetate, and 1 other intervention for Partial Epilepsy. Completed, enrolled 653 participants across 162 sites in 11 countries.
Detailed Summary
The purpose of this study is to determine whether Eslicarbazepine acetate (BIA 2-093) is an effective adjunct therapy in the treatment of refractory partial seizures
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsy
CountriesArgentina, Belgium, Brazil, Canada, Cyprus, France, Germany, Greece, Italy, Poland, United States
CollaboratorsSumitomo Pharma America, Inc.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedOct 2009
Primary CompletionJan 2012
TodayJul 2026
First PostedOct 2, 2009
Enrollment StartDec 2, 2008
Primary CompletionJan 12, 2012
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.8 years ago
Interventions
800 mg QD Eslicarbazepine acetatedrug
Oral, 800 mg QD, 2-week titration period and 12-week maintenance period
1200 mg QD Eslicarbazepine acetatedrug
Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period
Placebodrug
Placebo tablet given QD