Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
|Partial Epilepsy||Drug: 800 mg QD Eslicarbazepine acetate Drug: 1200 mg QD Eslicarbazepine acetate Drug: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Seizure Frequency Over the 12-week Maintenance Period. [ Time Frame: 12-week maintenance period (Week 3 to week 14) ]
- Proportion of Responders [ Time Frame: Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14) ]Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||July 2017|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 800 mg QD Eslicarbazepine acetate
Drug: 800 mg QD Eslicarbazepine acetate
Oral, 800 mg QD, 2-week titration period and 12-week maintenance period
Other Name: BIA 2-093
Active Comparator: 1200 mg QD Eslicarbazepine acetate
Drug: 1200 mg QD Eslicarbazepine acetate
Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period
Other Name: BIA 2-093
Placebo Comparator: Placebo
Placebo tablet given QD
Other Name: Sugar pills
The study was designed to include 3 parts; only the first part is described in this report. Part I of the study was an international, randomized, placebo-controlled, double-blind, parallel group, multicenter clinical study conducted in 19 countries at 173 sites in 653 subjects with refractory simple partial or complex partial seizures, with or without secondary generalization. After screening procedures and confirming eligibility, subjects entered Part I of the study, which consisted of 3 periods.
The first period was an 8 week observation baseline period (Week -8 to Week -1) during which subjects were instructed on how to complete the seizure diary. At the end of the 8 week observational baseline period, eligible subjects were randomized in a 1:1:1 allocation ratio to 1 of 3 treatment groups (with a blinded treatment assignment):
- ESL 800 mg QD
- ESL 1200 mg QD Subjects then entered the second period of Part 1, the 2 week, double blind, up titration period (Week 1 to Week 2). During this period, subjects in the ESL 800 mg group received ESL 400 mg QD, subjects in the ESL 1200 mg group received ESL 800 mg QD, and subjects in the placebo group received placebo QD.
Subjects then entered the third period of Part I, the 12 week, double-blind, maintenance period (Week 3 to Week 14) where subjects in the ESL 800 mg group received ESL 800 mg QD, subjects in the ESL 1200 mg group received ESL 1200 mg QD, and subjects in the placebo group received placebo QD.
At the completion of the maintenance period, subjects who did not enter Part II were to be tapered off study drug while maintaining the blind according to the following down titration procedure: subjects on 800 mg were down titrated to 400 mg for a duration of 2 weeks, and subjects on 1200 mg were down titrated to 800 mg for 1 week and then down-titrated to 400 mg for 1 week and subjects in the placebo group received placebo QD for 2 weeks. During Part I, 1 to 2 concomitant AEDs were allowed in this study and were to be kept stable during the course of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988429
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|Study Director:||Patrício Soares-da-Silva, MD, PHD||Bial - Portela & Cª, S.A.|