Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00988429 |
Recruitment Status : Unknown
Verified October 2018 by Bial - Portela C S.A..
Recruitment status was: Active, not recruiting
First Posted : October 2, 2009
Results First Posted : April 15, 2014
Last Update Posted : November 13, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Partial Epilepsy | Drug: 800 mg QD Eslicarbazepine acetate Drug: 1200 mg QD Eslicarbazepine acetate Drug: Placebo | Phase 3 |
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 (Clinical Trial) |
Actual Enrollment : | 653 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (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 |
Study Start Date : | December 2, 2008 |
Actual Primary Completion Date : | January 12, 2012 |
Estimated Study Completion Date : | January 2019 |

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 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 |
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
At V1 (screening), patient must be/have:
- Written informed consent signed by patient.
- 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.
- A documented diagnosis of epilepsy since at least 12 months prior to screening.
- 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.
- 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).
- Excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination findings, and clinical laboratory test results.
-
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:
- 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.
- In case of WOCBP, patient must present a urine B-hCG test consistent with a non gravid state.
- Diaries satisfactorily completed by the patient or his/her caregiver.
- 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:
- Only simple partial seizures with no motor symptomatology (classified as A2 4 according to the International Classification of Epileptic Seizures).
- Primarily generalised seizures.
- Known progressive neurological disorders (progressive brain disease; epilepsy secondary to progressive cerebral lesion).
- Occurrence of seizures too close to count accurately.
- History of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening.
- Seizures of non-epileptic origin.
- Seizures of psychogenic origin within the last 2 years.
- Major psychiatric disorders.
- 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.
- Currently treated with OXC.
- Using benzodiazepines on more than an occasional basis (defined as more than 2 times per week), except when used chronically as AED.
-
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).
- Known hypersensitivity to carboxamide derivatives.
- History of abuse of alcohol, drugs or medications within the last 2 years.
- Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder.
- Second or third-degree atrioventricular blockade not corrected with a pacemaker.
- 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.
- 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].
- Pregnant or nursing.
- 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.
- Not ensured capability to perform the trial.
- Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.
-
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:
- Inadequate compliance to concomitant AEDs during the 8-week baseline period or to screening exclusion criteria.
- Inadequate completion of the study diary.
- Any other condition or circumstance that, in the opinion of the Investigator, may compromise the patient's ability to comply with the study protocol.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988429

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 | |
Bradenton, Florida, United States, 34205 | |
Optima Neurological Services, LLC | |
Gainesville, Florida, United States, 32608 | |
University of Florida Department of Neurology | |
Gainesville, Florida, United States, 32610 | |
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 | |
Pharmax Research Clinic | |
Miami, Florida, United States, 33126 | |
Advanced Pharma CR, LLC | |
Miami, Florida, United States, 33136 | |
University of Miami - Miller School of Medicine Department of Neurology | |
Miami, Florida, United States, 33136 | |
Miami Children's Hospital | |
Miami, Florida, United States, 33155 | |
Neuroscience Consultants | |
Miami, Florida, United States, 33176 | |
Kendall South Medical Center, Inc. | |
Miami, Florida, United States, 33185 | |
Medsol Clinical Research Center | |
Port Charlotte, Florida, United States, 33952 | |
Lovelace Scientific Resources | |
Sarasota, Florida, United States, 34233 | |
University of South Florida - Department of Neurology | |
Tampa, Florida, United States, 33606 | |
Pediatric Epilepsy & Neurology Specialists, PA | |
Tampa, Florida, United States, 33609 | |
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. | |
Saint 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 | |
Beth Israel Medical Center | |
New York, New York, United States, 10003 | |
NYU Comprehensive Epilepsy Centre | |
New York, New York, United States, 10016 | |
Wiell Cornell Medical Centre Epilepsy Centre | |
New York, New York, United States, 10065 | |
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 | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
Comprehensive Epilepsy Center - Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
Temple University School of Medicine - Department of Neurology | |
Philadelphia, Pennsylvania, United States, 19140 | |
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 | |
Texas Neurology, PA | |
Dallas, Texas, United States, 75214 | |
Neurology Consultants of Dallas, P.A. | |
Dallas, Texas, United States, 75231 | |
Neurological Clinic of Texas | |
Dallas, Texas, United States, 75251 | |
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 | |
Innovative Clinical Trials | |
San Antonio, Texas, United States, 78229 | |
Road Runner Research | |
San Antonio, Texas, United States, 78258 | |
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 | |
Milwaukee, Wisconsin, United States, 53215 | |
Medical College of Wisconsin - Department of Neurology | |
Milwaukee, Wisconsin, United States, 53226 | |
Argentina | |
Hospital Privado de la comunidad de Mar de Plata | |
Buenos Aires, Argentina, 7600 | |
CEMIC | |
Buenos Aires, Argentina | |
Centro Neurológico de Tratamiento y Rehabilitación | |
Buenos Aires, Argentina | |
Hospital Italiano de Buenos Aires | |
Buenos Aires, Argentina | |
Hospital Ramos Mejía | |
Capital Federal, Argentina, 1221 | |
Hospital Británico | |
Capital Federal, Argentina, 1280 | |
Fleni | |
Capital Federal, Argentina, 1428 | |
Instituto Médico Especializado (IME) | |
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 | |
Irmandade da Santa Casa de Misericórdia de São Paulo | |
São Paulo, Brazil, SP01221-020 | |
Hospital Brigadeiro | |
São Paulo, Brazil, SP01401-901 | |
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 | |
Epilepsie-Zentrum Berlin Brandenburg am Evangelischen Krankenhaus Königin Elisabeth Herzberge | |
Berlin, Germany, 10365 | |
Charite, Universitätsmedizin Berlin, CVK | |
Berlin, Germany, 13353 | |
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 | |
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 |
Study Director: | Patrício Soares-da-Silva, MD, PHD | Bial - Portela & Cª, S.A. |
Responsible Party: | Bial - Portela C S.A. |
ClinicalTrials.gov Identifier: | NCT00988429 |
Other Study ID Numbers: |
BIA-2093-304 2008-002455-25 ( EudraCT Number ) |
First Posted: | October 2, 2009 Key Record Dates |
Results First Posted: | April 15, 2014 |
Last Update Posted: | November 13, 2018 |
Last Verified: | October 2018 |
Refractory partial epilepsy |
efficacy eslicarbazepine safety |
Epilepsy Seizures Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations |
Eslicarbazepine acetate Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |