CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 193 enrolled
Drug / intervention
Eslicarbazepine acetate +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.

Search/NCT00866775
NCT00866775Phase 3Completed
CompareCT.gov

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

Sumitomo Pharma America, Inc.·interventional·Posted Mar 20, 2009·Updated Mar 11, 2016

In Brief

A Phase 3 clinical trial evaluating Eslicarbazepine acetate for Epilepsy With Simple or Complex Partial Onset Seizures. Completed, enrolled 193 participants across 106 sites in 2 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 With Simple or Complex Partial Onset Seizures
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 20, 2009
Enrollment StartApr 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.3 years ago

Interventions

Eslicarbazepine acetatedrug

1600 mg QD

Eslicarbazepine acetatedrug

1200 mg QD