At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 172 enrolled
Drug / intervention
Eslicarbazepine acetate 1600 mg +1 moredrug
Likely dose
Eslicarbazepine acetate 1600 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.
Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
In Brief
A Phase 3 clinical trial evaluating Eslicarbazepine acetate 1600 mg and Eslicarbazepine acetate 1200 mg for Epilepsy. Completed, enrolled 172 participants across 62 sites in 5 countries.
Detailed Summary
This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBulgaria, Czechia, Serbia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartJun 2010
Primary CompletionNov 2012
TodayJul 2026
First PostedMar 24, 2010
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.3 years ago
Interventions
Eslicarbazepine acetate 1600 mgdrug
1600 mg once per day
Eslicarbazepine acetate 1200 mgdrug
1200 once per day