Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

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

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

Study Overview

• Status: Completed
• Conditions: Partial Epilepsy
• Intervention / Treatment: Drug: 800 mg QD Eslicarbazepine acetate; Drug: 1200 mg QD Eslicarbazepine acetate; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 653
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Hospital Italiano de Buenos Aires
  • Buenos Aires, Argentina
    • CEMIC
  • Buenos Aires, Argentina, 7600
    • Hospital Privado de la comunidad de Mar de Plata
  • Buenos Aires, Argentina
    • Centro Neurológico de Tratamiento y Rehabilitación
  • Capital Federal, Argentina, 1221
    • Hospital Ramos Mejia
  • Capital Federal, Argentina, 1280
    • Hospital Británico
  • Capital Federal, Argentina, 1428
    • FLENI
  • Capital Federal, Argentina, 1428
    • Instituto Médico Especializado (IME)
  • Cordoba, Argentina, 5016
    • Hospital Privado - Centro Médico de Córdoba S.A.
  • Cordoba, Argentina
    • Centro de Neurologia y Neurorehabilitacion
• Belgium
  • Ottignies, Belgium, 1340
    • Clinique Saint-Pierre
  • Ottignies, Belgium, 1340
    • Centre Neurologique William Lennox
  • Wilrijk, Belgium, 2610
    • AZ. Sint-Augustinus
• Brazil
  • Belo Horizonte, Brazil, MG30150-221
    • Santa Casa de Misericórdia de Belo Horizonte
  • Campinas, Brazil, SP13083-970
    • Hospital das Clinicas - UNICAMP
  • Curitiba, Brazil, PR81210-300
    • Instituto de Neurologia de Curitiba
  • Porto Alegre, Brazil, RS90035-003
    • Hospital de Clinicas de Porto Alegre
  • Porto Alegre, Brazil, RS90610-000
    • Hospital Sao Lucas - PUCRS
  • Ribeirão Preto, Brazil, SP14048-900
    • Hospital das Clinicas da FMRP
  • Santo André, Brazil, SP09060-650
    • Faculdade de Medicina do ABC
  • Sao Paulo, Brazil, SP04039-032
    • Hospital Sao Paulo - UNIFESP
  • São Paulo, Brazil, SP01221-020
    • Irmandade Da Santa Casa De Misericordia De Sao Paulo
  • São Paulo, Brazil, SP01401-901
    • Hospital Brigadeiro
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • University of Calgary Clinical Neurosciences
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H3V4
      • BC Children's Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3A2B4
      • Montreal Neurological Institute and Hospital
• Cyprus
  • Nikosia, Cyprus, 1683
    • The Cyprus Institute of Neurology
• France
  • Bordeaux, France, 33000
    • CENTRE HOSPITALIER PELLEGRIN, CHU de BORDEAUX
  • Bron, France, 69677 cedex
    • Hopital Femme-Mere-Enfant, Hospices Civils de Lyon
  • Lille, France, 59037
    • Hôpital Roger Salengro, CHRU de Lille
  • Montpellier, France, 34295
    • Hôpital Gui de Chauliac, CHU de Montpellier
  • Nancy, France, 54035 cedex
    • Hopital Central, Chu de Nancy
  • Paris, France, 75014
    • Centre Hospitalier Sainte-Anne
  • Rennes, France, 35033
    • Hopital Pontchaillou, Chru de Rennes
  • Strasbourg, France, 67091 cedex
    • Hopital Civil, Chru de Strasbourg
• Germany
  • Berlin, Germany, 10365
    • Epilepsie-Zentrum Berlin Brandenburg am Evangelischen Krankenhaus Königin Elisabeth Herzberge
  • Berlin, Germany, 13353
    • Charite, Universitätsmedizin Berlin, CVK
  • Essen, Germany
    • Universitätsklinikum Essen
  • Munich, Germany, 81925
    • Klinik für Neurologie, Klinische Neurophysiologie und Stroke Unit
  • Regensburg, Germany, 93053
    • Klinik und Poliklinik für Neurologie der Universität Regensburg im Bezirksklinikum
• Greece
  • Athens, Greece, 10676
    • Evangelismos General Hospital
  • Thessaloniki, Greece, 55236
    • Agios Loukas (St. Luke's) Hospital
  • Thessaloniki, Greece, 57010
    • General Hospital of Thessaloniki "Papanikolaou"
• Italy
  • Foggia, Italy, 71100
    • Azienda Ospedaliero, Universitaria "Ospedali Riuniti", Clinica della Malattie del Sistema Nervoso, Università di Foggia
  • Messina, Italy, 98125
    • A.O.U Policlinico di Messina
  • Napoli, Italy, 80131
    • Università degli Studi di Napoli Policlinico Federico II
  • Novara, Italy, 28100
    • Azienda Ospedaliero - Universitaria Maggiore della Carità
  • Pavia, Italy, 27100
    • Istituto Neurologico Casimiro Mondino
  • Roma, Italy, 00168
    • Università Cattolica del Sacro Cuore Policlinico "A. Gemelli"
  • Torino, Italy, 10126
    • Azienda Universitatia Ospedaliera San Giovanni Battista
• Poland
  • Kraków, Poland, 31-530
    • Centrum Neurologii Klinicznej
  • Lodz, Poland, 90-302
    • NZOZ Polimedica
  • Lublin, Poland, 20-178
    • Wojewódzki Szpital Specjalistyczny w Lublinie Oddzial Neurologii
  • Olsztyn, Poland, 10-561
    • Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddzial Neurologii
  • Poznan, Poland, 61-289
    • NZOZ "NEURO - KARD,"Ilkowski I Partnerzy Spólka, Partnerska Lekarzy
  • Warszawa, Poland, 02-957
    • Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna
• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • University of South Alabama Department of Neurology
    • Northport, Alabama, United States, 35476
      • Neurology Clinic, P.C.
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • 21st Century Neurology - Division of Xenoscience, Inc.
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
    • Phoenix, Arizona, United States, 85018
      • Phoenix Neurological Associates/Clinical Research Advantage
    • Sun City, Arizona, United States, 85351
      • ANI Research, PC
    • Tucson, Arizona, United States, 86724
      • University of Arizona Health Sciences Center
  • Arkansas
    • Conway, Arkansas, United States, 72034
      • Arkansas Neurology
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials Inc.
  • California
    • Bakersfield, California, United States, 93301
      • Kern County Neurological Medical Group, INC.
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center, Inc.
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Network, Inc
    • Murrieta, California, United States, 92562
      • Viking Clinical Research Center
    • San Francisco, California, United States, 94104
      • Bright Minds Institute
    • San Jose, California, United States, 95124
      • Milestone Clinical Research
    • Ventura, California, United States, 93003
      • Neurosearch II, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences
    • Denver, Colorado, United States, 80204
      • Denver Health
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center
    • Gainesville, Florida, United States, 32608
      • Optima Neurological Services, LLC
    • Gainesville, Florida, United States, 32610
      • University of Florida Department of Neurology
    • Gulf Breeze, Florida, United States, 32561
      • NW FL Clinical Research Group, LLC
    • Hialeah, Florida, United States, 33012
      • Palm Springs Research Institute
    • Jacksonville, Florida, United States, 32209
      • University of Florida
    • Miami, Florida, United States, 33126
      • Pharmax Research Clinic
    • Miami, Florida, United States, 33155
      • Miami Children's Hospital
    • Miami, Florida, United States, 33185
      • Kendall South Medical Center, Inc.
    • Miami, Florida, United States, 33136
      • Advanced Pharma CR, LLC
    • Miami, Florida, United States, 33176
      • Neuroscience Consultants
    • Miami, Florida, United States, 33136
      • University of Miami - Miller School of Medicine Department of Neurology
    • Port Charlotte, Florida, United States, 33952
      • Medsol Clinical Research Center
    • Sarasota, Florida, United States, 34233
      • Lovelace Scientific Resources
    • Tampa, Florida, United States, 33609
      • Pediatric Epilepsy & Neurology Specialists, PA
    • Tampa, Florida, United States, 33606
      • University of South Florida - Department of Neurology
    • Venice, Florida, United States, 34292
      • Lovelace Scientific Resources
    • Wellington, Florida, United States, 33414
      • Palm Beach Clinical Research Network, LLC.
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
  • Idaho
    • Boise, Idaho, United States, 83702
      • Consultants in Epilepsy and Neurology, PPLC
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Southern Ilinois University School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Josephson Wallack Munshower Neurology P.C.
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC
    • Des Moines, Iowa, United States, 50314
      • Broadlawns Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates, Inc.
    • New Orleans, Louisiana, United States, 70112
      • LSUHSC Epilepsy Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
    • Baltimore, Maryland, United States, 21204
      • University of Maryland Medical Center
    • Bethesda, Maryland, United States, 20817
      • Mid-Atlantic Epilepsy and Sleep Centre
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • MGH Epilepsy Service Massachusetts, General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University/Detroit Medical Center
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology, Ltd
    • Saint Paul, Minnesota, United States, 55102
      • Minnesota Epilepsy Group, P.A.
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Comprehensive Epilepsy Care Centre for Chidren and Adults
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • The Cooper Health System
    • Gibbsboro, New Jersey, United States, 08026
      • Clinical Research Centre of New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Northeast Regional Epilepsy Group
    • New Brunswick, New Jersey, United States, 08901
      • UMDNJ-Robert Wood Johnson Medical School
    • Paterson, New Jersey, United States, 07503
      • St. Joseph Regional Medical Center
    • Toms River, New Jersey, United States, 08755
      • Shore Neurology, PA
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College - Neurosciences Institute
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Cedarhurst, New York, United States, 11516
      • Five Towns Neuroscience Research
    • Liverpool, New York, United States, 13088
      • Neurological Care of CNY
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10016
      • NYU Comprehensive Epilepsy Centre
    • New York, New York, United States, 10065
      • Wiell Cornell Medical Centre Epilepsy Centre
    • Orchard Park, New York, United States, 14127
      • Dent Neurologic Institute
    • Rochester, New York, United States, 14642
      • Strong Epilepsy Center - University of Rochester Medical Center
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • The Neurological Institute, P.A.
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
    • Wilmington, North Carolina, United States, 28401
      • Wilmington Medical Research
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Centre
    • Dayton, Ohio, United States, 45417
      • Neurology Specialists, Inc
    • Toledo, Ohio, United States, 43614
      • University of Toledo - Health Science Campus
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Tulsa, Oklahoma, United States, 74104
      • Tulsa Clinical Reserch
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107
      • Comprehensive Epilepsy Center - Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University School of Medicine - Department of Neurology
    • Pittsburgh, Pennsylvania, United States, 15224
      • Childrens Hospital of Pittsburg of UPMC - Division of Child Neurology
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Brownwood, Texas, United States, 76801
      • Private Practice of Dr. Edwin Green
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
    • Dallas, Texas, United States, 75231
      • Neurology Consultants of Dallas, P.A.
    • Dallas, Texas, United States, 75251
      • Neurological Clinic of Texas
    • Dallas, Texas, United States, 75390
      • UTSWMC Department of Neurology, Division of Epilepsy Research
    • DeSoto, Texas, United States, 75115
      • Medistat Clinical Research
    • DeSoto, Texas, United States, 75115
      • Nemmar Clinical Resources
    • Houston, Texas, United States, 77063
      • Houston Neurology and Sleep Center
    • San Antonio, Texas, United States, 78258
      • Road Runner Research
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital Sherwood and Brindley Foundation
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia - Comprehensive Epilepsy Program
    • Norfolk, Virginia, United States, 23507
      • Sentara Medical Group, Neurology Specialists Sentara Heart Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • Neurological Associates of Washington/Clinical Trials of America, Inc
    • Renton, Washington, United States, 98057
      • Ranier Clinical Research Center
    • Seattle, Washington, United States, 98104
      • University Washington Regional Epilepsy Center Harborview
    • Tacoma, Washington, United States, 98405
      • MultiCare Adult Neurology
  • Wisconsin
    • Madison, Wisconsin, United States, 53715
      • Dean & St. Mary's Outpatient Center Neurological Institute and Spine Center
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic
    • Milwaukee, Wisconsin, United States, 53215
      • Regional Epilepsy Centre of Aurora Healthcare- St. Luke's Medical Centre
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin - Department of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

At V1 (screening), patient must be/have:

1. Written informed consent signed by patient.
2. Aged 16 years or more (patients under 18 years of age require parental/legal representative consent). In North America as well as in other participating countries, when appropriate and/or required by state or local law, minor patients must give written informed assent prior to participation in the study.
3. A documented diagnosis of epilepsy since at least 12 months prior to screening.
4. At least 4 partial-onset seizures (including subtypes of simple partial, complex partial and partial seizures evolving to secondarily generalised) on the 4 weeks prior to screening.
5. Currently treated with 1 or 2 AEDs (any except OXC), in a stable dose regimen during at least 1 month prior to screening. Patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified (a confirmatory test should be available within 1 month before study entry). The device for VNS should be implanted at least 6 months before screening; parameters need to be stable for at least 1 month prior to screening (VNS will not be counted as concomitant AED).
6. Excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination findings, and clinical laboratory test results.

7. Post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation. In case of women of childbearing potential (WOCBP), patient must present a serum beta-human chorionic gonadotropin (B-hCG) test consistent with a non gravid state and agree to remain abstinent or use reliable contraception (hormonal contraception should be combined with a barrier method) beginning at screening and continuing at least to the PSV.

   At V2 (randomisation), patient must have:

8. At least 8 partial-onset seizures during baseline with at least 3 partial-onset seizures in each 4-week section of the 8-week baseline period prior to randomisation (documented in a diary) and no seizure-free interval exceeding 28 consecutive days.
9. In case of WOCBP, patient must present a urine B-hCG test consistent with a non gravid state.
10. Diaries satisfactorily completed by the patient or his/her caregiver.
11. Satisfactorily complied with the study requirements during the baseline period (including no changes in concomitant AED therapy should have occurred in the baseline period).

Exclusion Criteria

At V1 (screening), patients must not be/have:

1. Only simple partial seizures with no motor symptomatology (classified as A2 4 according to the International Classification of Epileptic Seizures).
2. Primarily generalised seizures.
3. Known progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion).
4. Occurrence of seizures too close to count accurately.
5. History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
6. Seizures of non-epileptic origin.
7. Seizures of psychogenic origin within the last 2 years.
8. Major psychiatric disorders.
9. Documented diagnosis of schizophrenia with accompanying documented history of at least 1 acute psychosis episode within the last 2 years) or history of suicide attempt.
10. Currently treated with OXC.
11. Using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as AED.

12. Known exposure to Eslicarbazepine acetate from previous study.

    o Previous use of Eslicarbazepine acetate or participation in a clinical study with Eslicarbazepine acetate (patients not exposed to Eslicarbazepine acetate [e.g., screen failed] are allowed).

13. Known hypersensitivity to carboxamide derivatives.
14. History of abuse of alcohol, drugs or medications within the last 2 years.
15. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
16. Second or third-degree atrioventricular blockade not corrected with a pacemaker.
17. Relevant clinical laboratory abnormalities (e.g., sodium <130 mmol/L, alanine or aspartate transaminases >2.0 times the upper limit of the normal, white blood cell [WBC] count <3,000 cells/mm3) or for patients of Asian ancestry, positive HLA B*1502 test.
18. Estimated creatinine clearance <60 mL/min [men: (140-age) x weight/serum creatinine x 72; women: (0.85) (140-age) x weight/serum creatinine x 72. Age in years, weight in kg, and serum creatinine in mg/dL].
19. Pregnant or nursing.
20. Participation in other drug clinical trial within the last 2 months or received an investigational drug within 5 half-lives of this other product, whichever is longer. Patient(s) who are known to have not taken any doses of study drug(s) in earlier study(ies) (e.g. screen-failures) are allowed without any time limitation.
21. Not ensured capability to perform the trial.
22. Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.

23. Currently treated with VNS, but implanted <6 months before screening or parameters not stable for at least 1 month prior to screening.

    At V2 (randomisation), patients must not be/have:

24. Inadequate compliance to concomitant AEDs during the 8-week baseline period or to screening exclusion criteria.
25. Inadequate completion of the study diary.
26. Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 800 mg QD Eslicarbazepine acetate; tablets	Drug: 800 mg QD Eslicarbazepine acetate; Oral, 800 mg QD, 2-week titration period and 12-week maintenance period; Other Names: BIA 2-093
ACTIVE_COMPARATOR: 1200 mg QD Eslicarbazepine acetate; tablets	Drug: 1200 mg QD Eslicarbazepine acetate; Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period; Other Names: BIA 2-093
PLACEBO_COMPARATOR: Placebo; tablets	Drug: Placebo; Placebo tablet given QD; Other Names: Sugar pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Seizure Frequency Over the 12-week Maintenance Period.	12-week maintenance period (Week 3 to week 14)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Responders	Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.	Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)

Collaborators and Investigators

• Sponsor: Bial - Portela C S.A.
• Collaborators: Sunovion

Publications and helpful links

General Publications

• Andermann E, Rosenfeld W, Penovich P, Rogin J, Cendes F, Carreno M, Ramsay RE, Ben-Menachem E, Gama H, Rocha F, Soares-da-Silva P, Tosiello R, Blum D, Grinnell T. Comparative analysis of the safety and tolerability of eslicarbazepine acetate in older (>/=60 years) and younger (18-59 years) adults. Epilepsy Res. 2021 Jan;169:106478. doi: 10.1016/j.eplepsyres.2020.106478. Epub 2020 Oct 10.
• Cramer JA, Colman S, Anastassopoulos KP, Grinnell T, Mehta D, Williams GR. Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results. Epilepsy Behav. 2020 Nov;112:107312. doi: 10.1016/j.yebeh.2020.107312. Epub 2020 Aug 12.

Study record dates

Study Major Dates

• Study Start: December 2, 2008
• Primary Completion (ACTUAL): January 12, 2012
• Study Completion (ACTUAL): January 12, 2012

Study Registration Dates

• First Submitted: October 1, 2009
• First Submitted That Met QC Criteria: October 1, 2009
• First Posted (ESTIMATE): October 2, 2009

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: safety; epilepsy; Refractory; efficacy; partial; eslicarbazepine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: BIA-2093-304; 2008-002455-25 (EUDRACT_NUMBER)