CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 123 enrolled
Drug / intervention
Eslicarbazepine acetate (BIA 2-093) +1 moredrug
Likely dose
Eslicarbazepine acetate (BIA 2-093) 200 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/NCT01527513
NCT01527513Phase 2Completed
CompareCT.gov

Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures: an add-on, Double-blind, Randomised, Placebo-controlled, Parallel Group, Multicentre Clinical Trial

Bial - Portela C S.A.·interventional·Posted Feb 7, 2012·Updated Oct 24, 2014

In Brief

A Phase 2 clinical trial evaluating Eslicarbazepine acetate (BIA 2-093) and Placebo for Partial Epilepsy. Completed, enrolled 123 participants across 36 sites in 5 countries.

Detailed Summary

To evaluate the effects of eslicarbazepine acetate on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Epilepsy
CountriesItaly, Netherlands, Poland, Russia, Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2012
Enrollment StartAug 1, 2010
Primary CompletionMar 1, 2012
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.4 years ago

Interventions

Eslicarbazepine acetate (BIA 2-093)drug

Eslicarbazepine acetate (ESL) tablets 200 mg and the matching placebo will be supplied. Treatments will be administered by oral route, once-daily, in the evening. The dose will be rounded to the nearest 100 mg unit. Half tablets may be used for dose adjustment if necessary.

Placebodrug

Treatments will be administered by oral route, once-daily, in the evening.