Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
- Conditions
- Partial Epilepsy
- Interventions
- Registration Number
- NCT00988429
- Lead Sponsor
- Bial - Portela C S.A.
- Brief 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
- Detailed Description
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):
* Placebo
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 653
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 800 mg QD Eslicarbazepine acetate 800 mg QD Eslicarbazepine acetate tablets 1200 mg QD Eslicarbazepine acetate 1200 mg QD Eslicarbazepine acetate tablets Placebo Placebo tablets
- Primary Outcome Measures
Name Time Method Seizure Frequency Over the 12-week Maintenance Period. 12-week maintenance period (Week 3 to week 14)
- Secondary Outcome Measures
Name Time Method Proportion of Responders 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.
Trial Locations
- Locations (161)
University of South Alabama Department of Neurology
🇺🇸Mobile, Alabama, United States
Neurology Clinic, P.C.
🇺🇸Northport, Alabama, United States
21st Century Neurology - Division of Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Phoenix Neurological Associates/Clinical Research Advantage
🇺🇸Phoenix, Arizona, United States
ANI Research, PC
🇺🇸Sun City, Arizona, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Arkansas Neurology
🇺🇸Conway, Arkansas, United States
Clinical Trials Inc.
🇺🇸Little Rock, Arkansas, United States
Kern County Neurological Medical Group, INC.
🇺🇸Bakersfield, California, United States
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