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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00988429
First received: October 1, 2009
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Partial Epilepsy
Drug: 800 mg QD Eslicarbazepine acetate
Drug: 1200 mg QD Eslicarbazepine acetate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bial - Portela C S.A.:

Primary Outcome Measures:
  • Seizure Frequency Over the 12-week Maintenance Period. [ Time Frame: 12-week maintenance period (Week 3 to week 14) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Responders [ Time Frame: Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14) ] [ Designated as safety issue: No ]
    Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.


Enrollment: 653
Study Start Date: December 2008
Estimated Study Completion Date: February 2015
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: BIA 2-093
Placebo Comparator: Placebo
tablets
Drug: Placebo
Placebo tablet given QD
Other Name: Sugar pills

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00988429

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Department of Neurology
Mobile, Alabama, United States, 36693
Neurology Clinic, P.C.
Northport, Alabama, United States, 35476
United States, Arizona
21st Century Neurology - Division of Xenoscience, Inc.
Phoenix, Arizona, United States, 85004
Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Phoenix Neurological Associates/Clinical Research Advantage
Phoenix, Arizona, United States, 85018
ANI Research, PC
Sun City, Arizona, United States, 85351
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 86724
United States, Arkansas
Arkansas Neurology
Conway, Arkansas, United States, 72034
Clinical Trials Inc.
Little Rock, Arkansas, United States, 72205
United States, California
Kern County Neurological Medical Group, INC.
Bakersfield, California, United States, 93301
Neuro-Pain Medical Center, Inc.
Fresno, California, United States, 93710
Loma Linda University
Loma Linda, California, United States, 92354
Collaborative Neuroscience Network, INC
Long Beach, California, United States, 90806
Viking Clinical Research Center
Murrieta, California, United States, 92562
Bright Minds Institute
San Francisco, California, United States, 94104
Milestone Clinical Research
San Jose, California, United States, 95124
Neurosearch II, Inc.
Ventura, California, United States, 93003
United States, Colorado
University of Colorado Health Sciences
Aurora, Colorado, United States, 80045
Denver Health
Denver, Colorado, United States, 80204
United States, Florida
Bradenton Research Center
Brandenton, Florida, United States, 34205
University of Florida Department of Neurology
Gainesville, Florida, United States, 32610
Optima Neurological Services, LLC
Gainesville, Florida, United States, 32608
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States, 32561
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
University of Florida
Jacksonville, Florida, United States, 32209
University of Miami - Miller School of Medicine Department of Neurology
Miami, Florida, United States, 33136
Advanced Pharma CR, LLC
Miami, Florida, United States, 33136
Pharmax Research Clinic
Miami, Florida, United States, 33126
Kendall South Medical Center, Inc.
Miami, Florida, United States, 33185
Miami Children's Hospital
Miami, Florida, United States, 33155
Neuroscience Consultants
Miami, Florida, United States, 33176
Medsol Clinical Research Center
Port Charlotte, Florida, United States, 33952
Lovelace Scientific Resources
Sarasota, Florida, United States, 34233
Pediatric Epilepsy & Neurology Specialists, PA
Tampa, Florida, United States, 33609
University of South Florida - Department of Neurology
Tampa, Florida, United States, 33606
Lovelace Scientific Resources
Venice, Florida, United States, 34292
Palm Beach Clinical Research Network, LLC.
Wellington, Florida, United States, 33414
United States, Georgia
Harbin Clinic
Rome, Georgia, United States, 30165
United States, Idaho
Consultants in Epilepsy and Neurology, PPLC
Boise, Idaho, United States, 83702
United States, Illinois
Southern Ilinois University School of Medicine
Springfield, Illinois, United States, 62702
United States, Indiana
Josephson Wallack Munshower Neurology P.C.
Indianapolis, Indiana, United States, 46237
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
LSUHSC Epilepsy Center
New Orleans, Louisiana, United States, 70112
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States, 70114
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21204
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Mid-Atlantic Epilepsy and Sleep Centre
Bethesda, Maryland, United States, 20817
United States, Massachusetts
MGH Epilepsy Service Massachusetts, General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Wayne State University/Detroit Medical Center
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis Clinic of Neurology, Ltd
Golden Valley, Minnesota, United States, 55422
Minnesota Epilepsy Group, P.A.
St. Paul, Minnesota, United States, 55102
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
United States, Missouri
The Comprehensive Epilepsy Care Centre for Chidren and Adults
Chesterfield, Missouri, United States, 63017
United States, New Jersey
The Cooper Health System
Camden, New Jersey, United States, 08103
Clinical Research Centre of New Jersey
Gibbsboro, New Jersey, United States, 08026
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
St. Joseph Regional Medical Center
Paterson, New Jersey, United States, 07503
Shore Neurology, PA
Toms River, New Jersey, United States, 08755
United States, New York
Albany Medical College - Neurosciences Institute
Albany, New York, United States, 12208
Montefiore Medical Center
Bronx, New York, United States, 10467
Five Towns Neuroscience Research
Cedarhurst, New York, United States, 11516
Neurological Care of CNY
Liverpool, New York, United States, 13088
Wiell Cornell Medical Centre Epilepsy Centre
New York, New York, United States, 10065
NYU Comprehensive Epilepsy Centre
New York, New York, United States, 10016
Beth Israel Medical Center
New York, New York, United States, 10003
Dent Neurologic Institute
Orchard Park, New York, United States, 14127
Strong Epilepsy Center - University of Rochester Medical Center
Rochester, New York, United States, 14642
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
The Neurological Institute, P.A.
Charlotte, North Carolina, United States, 28204
PMG Research of Hickory, LLC
Hickory, North Carolina, United States, 28602
Wilmington Medical Research
Wilmington, North Carolina, United States, 28401
United States, Ohio
Ohio State University Medical Centre
Columbus, Ohio, United States, 43210
Neurology Specialists, Inc
Dayton, Ohio, United States, 45417
University of Toledo - Health Science Campus
Toledo, Ohio, United States, 43614
United States, Oklahoma
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Tulsa Clinical Reserch
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Temple University School of Medicine - Department of Neurology
Philadelphia, Pennsylvania, United States, 19140
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Comprehensive Epilepsy Center - Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Childrens Hospital of Pittsburg of UPMC - Division of Child Neurology
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Private Practice of Dr. Edwin Green
Brownwood, Texas, United States, 76801
Neurological Clinic of Texas
Dallas, Texas, United States, 75251
Texas Neurology, PA
Dallas, Texas, United States, 75214
Neurology Consultants of Dallas, P.A.
Dallas, Texas, United States, 75231
UTSWMC Department of Neurology, Division of Epilepsy Research
Dallas, Texas, United States, 75390
Medistat Clinical Research
Desoto, Texas, United States, 75115
Nemmar Clinical Resources
Desoto, Texas, United States, 75115
Houston Neurology and Sleep Center
Houston, Texas, United States, 77063
Road Runner Research
San Antonio, Texas, United States, 78258
Innovative Clinical Trials
San Antonio, Texas, United States, 78229
Scott and White Memorial Hospital Sherwood and Brindley Foundation
Temple, Texas, United States, 76508
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
University of Virginia - Comprehensive Epilepsy Program
Charlottesville, Virginia, United States, 22903
Sentara Medical Group, Neurology Specialists Sentara Heart Hospital
Norfolk, Virginia, United States, 23507
United States, Washington
Neurological Associates of Washington/Clinical Trials of America, Inc
Bellevue, Washington, United States, 98004
Ranier Clinical Research Center
Renton, Washington, United States, 98057
University Washington Regional Epilepsy Center Harborview
Seattle, Washington, United States, 98104
MultiCare Adult Neurology
Tacoma, Washington, United States, 98405
United States, Wisconsin
Dean & St. Mary's Outpatient Center Neurological Institute and Spine Center
Madison, Wisconsin, United States, 53715
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Regional Epilepsy Centre of Aurora Healthcare- St. Luke's Medical Centre
Milwakee, Wisconsin, United States, 53215
Medical College of Wisconsin - Department of Neurology
Milwaukee, Wisconsin, United States, 53226
Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
CEMIC
Buenos Aires, Argentina
Hospital Privado de la comunidad de Mar de Plata
Buenos Aires, Argentina, 7600
Centro Neurológico de Tratamiento y Rehabilitación
Buenos Aires, Argentina
Hospital Ramos Mejía
Capital Federal, Argentina, 1221
Hospital Británico
Capital Federal, Argentina, 1280
Instituto Médico Especializado (IME)
Capital Federal, Argentina, 1428
Fleni
Capital Federal, Argentina, 1428
Hospital Privado - Centro Médico de Córdoba S.A.
Cordoba, Argentina, 5016
Centro de Neurologia y Neurorehabilitacion
Cordoba, Argentina
Belgium
Centre Neurologique William Lennox
Ottignies, Belgium, 1340
Clinique Saint-Pierre
Ottignies, Belgium, 1340
AZ. Sint-Augustinus
Wilrijk, Belgium, 2610
Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Brazil, MG30150-221
Hospital das Clínicas - UNICAMP
Campinas, Brazil, SP13083-970
Instituto de Neurologia de Curitiba
Curitiba, Brazil, PR81210-300
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil, RS90035-003
Hospital São Lucas - PUCRS
Porto Alegre, Brazil, RS90610-000
Hospital das Clinicas da FMRP
Ribeirão Preto, Brazil, SP14048-900
Faculdade de Medicina do ABC
Santo André, Brazil, SP09060-650
Hospital São Paulo - UNIFESP
Sao Paulo, Brazil, SP04039-032
Hospital Brigadeiro
São Paulo, Brazil, SP01401-901
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil, SP01221-020
Canada, Alberta
University of Calgary Clinical Neurosciences
Calgary, Alberta, Canada, T2N2T9
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H3V4
Canada, Quebec
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A2B4
Cyprus
The Cyprus Institute of Neurology
Nikosia, Cyprus, 1683
France
CENTRE HOSPITALIER PELLEGRIN, CHU de BORDEAUX
Bordeaux, France, 33000
Hopital Femme-Mere-Enfant, Hospices Civils de Lyon
Bron, France, 69677 cedex
Hopital Roger Salengro, Chru de Lille
Lille, France, 59037
Hopital Gui de Chauliac, Chu de Montpellier
Montpellier, France, 34295
Hopital Central, Chu de Nancy
Nancy, France, 54035 cedex
Centre Hospitalier Sainte-Anne
Paris, France, 75014
Hopital Pontchaillou, Chru de Rennes
Rennes, France, 35033
Hopital Civil, Chru de Strasbourg
Strasbourg, France, 67091 cedex
Germany
Charite, Universitätsmedizin Berlin, CVK
Berlin, Germany, 13353
Epilepsie-Zentrum Berlin Brandenburg am Evangelischen Krankenhaus Königin Elisabeth Herzberge
Berlin, Germany, 10365
Universitätsklinikum Essen
Essen, Germany
Klinik für Neurologie, Klinische Neurophysiologie und Stroke Unit
Munich, Germany, 81925
Klinik und Poliklinik für Neurologie der Universität Regensburg im Bezirksklinikum
Regensburg, Germany, 93053
Greece
Evangelismos General Hospital
Athens, Greece, 10676
Agios Loukas (St. Luke's) Hospital
Thessaloniki, Greece, 55236
General Hospital of Thessaloniki "Papanikolaou"
Thessaloniki, Greece, 57010
Italy
Azienda Ospedaliero, Universitaria "Ospedali Riuniti", Clinica della Malattie del Sistema Nervoso, Università di Foggia
Foggia, Italy, 71100
A.O.U Policlinico di Messina
Messina, Italy, 98125
Ospedale San Paolo
Milano, Italy, 20142
Università degli Studi di Napoli Policlinico Federico II
Napoli, Italy, 80131
Azienda Ospedaliero - Universitaria Maggiore della Carità
Novara, Italy, 28100
Istituto Neurologico Casimiro Mondino
Pavia, Italy, 27100
Università Cattolica del Sacro Cuore Policlinico "A. Gemelli"
Roma, Italy, 00168
Azienda Universitatia Ospedaliera San Giovanni Battista
Torino, Italy, 10126
Poland
Centrum Neurologii Klinicznej
Kraków, Poland, 31-530
NZOZ Polimedica
Lodz, Poland, 90-302
Wojewódzki Szpital Specjalistyczny w Lublinie Oddzial Neurologii
Lublin, Poland, 20-178
Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddzial Neurologii
Olsztyn, Poland, 10-561
NZOZ "NEURO - KARD,"Ilkowski I Partnerzy Spólka, Partnerska Lekarzy
Poznan, Poland, 61-289
Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna
Warszawa, Poland, 02-957
Sponsors and Collaborators
Bial - Portela C S.A.
Sunovion
Investigators
Study Director: Patrício Soares-da-Silva, MD, PHD Bial - Portela & Cª, S.A.
  More Information

No publications provided

Responsible Party: Bial - Portela C S.A.
ClinicalTrials.gov Identifier: NCT00988429     History of Changes
Other Study ID Numbers: BIA-2093-304, 2008-002455-25
Study First Received: October 1, 2009
Results First Received: December 3, 2013
Last Updated: March 10, 2014
Health Authority: Brazil: National Health Surveillance Agency
United States: Food and Drug Administration

Keywords provided by Bial - Portela C S.A.:
Refractory
partial
epilepsy
efficacy
eslicarbazepine
safety

Additional relevant MeSH terms:
Epilepsies, Partial
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eslicarbazepine acetate
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 22, 2014