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

Primary Purpose

Partial Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
800 mg QD Eslicarbazepine acetate
1200 mg QD Eslicarbazepine acetate
Placebo
Sponsored by
Bial - Portela C S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Epilepsy focused on measuring Refractory, partial, epilepsy, efficacy, eslicarbazepine, safety

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Alabama Department of Neurology
  • Neurology Clinic, P.C.
  • 21st Century Neurology - Division of Xenoscience, Inc.
  • Barrow Neurological Institute / St. Joseph's Hospital and Medical Center
  • Phoenix Neurological Associates/Clinical Research Advantage
  • ANI Research, PC
  • University of Arizona Health Sciences Center
  • Arkansas Neurology
  • Clinical Trials Inc.
  • Kern County Neurological Medical Group, INC.
  • Neuro-Pain Medical Center, Inc.
  • Loma Linda University
  • Collaborative Neuroscience Network, INC
  • Viking Clinical Research Center
  • Bright Minds Institute
  • Milestone Clinical Research
  • Neurosearch II, Inc.
  • University of Colorado Health Sciences
  • Denver Health
  • Bradenton Research Center
  • Optima Neurological Services, LLC
  • University of Florida Department of Neurology
  • NW FL Clinical Research Group, LLC
  • Palm Springs Research Institute
  • University of Florida
  • Pharmax Research Clinic
  • Advanced Pharma CR, LLC
  • University of Miami - Miller School of Medicine Department of Neurology
  • Miami Children's Hospital
  • Neuroscience Consultants
  • Kendall South Medical Center, Inc.
  • Medsol Clinical Research Center
  • Lovelace Scientific Resources
  • University of South Florida - Department of Neurology
  • Pediatric Epilepsy & Neurology Specialists, PA
  • Lovelace Scientific Resources
  • Palm Beach Clinical Research Network, LLC.
  • Harbin Clinic
  • Consultants in Epilepsy and Neurology, PPLC
  • Southern Ilinois University School of Medicine
  • Josephson Wallack Munshower Neurology P.C.
  • McFarland Clinic, PC
  • Broadlawns Medical Center
  • University of Kentucky
  • LSUHSC Epilepsy Center
  • Louisiana Research Associates, Inc.
  • University of Maryland Medical Center
  • Johns Hopkins University
  • Mid-Atlantic Epilepsy and Sleep Centre
  • MGH Epilepsy Service Massachusetts, General Hospital
  • Wayne State University/Detroit Medical Center
  • Minneapolis Clinic of Neurology, Ltd
  • Minnesota Epilepsy Group, P.A.
  • Precise Research Centers
  • The Comprehensive Epilepsy Care Centre for Chidren and Adults
  • The Cooper Health System
  • Clinical Research Centre of New Jersey
  • Northeast Regional Epilepsy Group
  • UMDNJ-Robert Wood Johnson Medical School
  • St. Joseph Regional Medical Center
  • Shore Neurology, PA
  • Albany Medical College - Neurosciences Institute
  • Montefiore Medical Center
  • Five Towns Neuroscience Research
  • Neurological Care of CNY
  • Beth Israel Medical Center
  • NYU Comprehensive Epilepsy Centre
  • Wiell Cornell Medical Centre Epilepsy Centre
  • Dent Neurologic Institute
  • Strong Epilepsy Center - University of Rochester Medical Center
  • SUNY Upstate Medical University
  • The Neurological Institute, P.A.
  • PMG Research of Hickory, LLC
  • Wilmington Medical Research
  • Ohio State University Medical Centre
  • Neurology Specialists, Inc
  • University of Toledo - Health Science Campus
  • Lynn Health Science Institute
  • Tulsa Clinical Reserch
  • Children's Hospital of Philadelphia
  • Comprehensive Epilepsy Center - Thomas Jefferson University
  • Temple University School of Medicine - Department of Neurology
  • Childrens Hospital of Pittsburg of UPMC - Division of Child Neurology
  • Vanderbilt University Medical Center
  • Private Practice of Dr. Edwin Green
  • Texas Neurology, PA
  • Neurology Consultants of Dallas, P.A.
  • Neurological Clinic of Texas
  • UTSWMC Department of Neurology, Division of Epilepsy Research
  • Medistat Clinical Research
  • Nemmar Clinical Resources
  • Houston Neurology and Sleep Center
  • Innovative Clinical Trials
  • Road Runner Research
  • Scott and White Memorial Hospital Sherwood and Brindley Foundation
  • Wasatch Clinical Research
  • University of Virginia - Comprehensive Epilepsy Program
  • Sentara Medical Group, Neurology Specialists Sentara Heart Hospital
  • Neurological Associates of Washington/Clinical Trials of America, Inc
  • Ranier Clinical Research Center
  • University Washington Regional Epilepsy Center Harborview
  • MultiCare Adult Neurology
  • Dean & St. Mary's Outpatient Center Neurological Institute and Spine Center
  • Marshfield Clinic
  • Regional Epilepsy Centre of Aurora Healthcare- St. Luke's Medical Centre
  • Medical College of Wisconsin - Department of Neurology
  • Hospital Privado de la comunidad de Mar de Plata
  • CEMIC
  • Centro Neurológico de Tratamiento y Rehabilitación
  • Hospital Italiano de Buenos Aires
  • Hospital Ramos Mejía
  • Hospital Británico
  • Fleni
  • Instituto Médico Especializado (IME)
  • Hospital Privado - Centro Médico de Córdoba S.A.
  • Centro de Neurologia y Neurorehabilitacion
  • Centre Neurologique William Lennox
  • Clinique Saint-Pierre
  • AZ. Sint-Augustinus
  • Santa Casa de Misericórdia de Belo Horizonte
  • Hospital das Clínicas - UNICAMP
  • Instituto de Neurologia de Curitiba
  • Hospital de Clínicas de Porto Alegre
  • Hospital São Lucas - PUCRS
  • Hospital das Clinicas da FMRP
  • Faculdade de Medicina do ABC
  • Hospital São Paulo - UNIFESP
  • Irmandade da Santa Casa de Misericórdia de São Paulo
  • Hospital Brigadeiro
  • University of Calgary Clinical Neurosciences
  • BC Children's Hospital
  • Montreal Neurological Institute and Hospital
  • The Cyprus Institute of Neurology
  • CENTRE HOSPITALIER PELLEGRIN, CHU de BORDEAUX
  • Hopital Femme-Mere-Enfant, Hospices Civils de Lyon
  • Hopital Roger Salengro, Chru de Lille
  • Hopital Gui de Chauliac, Chu de Montpellier
  • Hopital Central, Chu de Nancy
  • Centre Hospitalier Sainte-Anne
  • Hopital Pontchaillou, Chru de Rennes
  • Hopital Civil, Chru de Strasbourg
  • Epilepsie-Zentrum Berlin Brandenburg am Evangelischen Krankenhaus Königin Elisabeth Herzberge
  • Charite, Universitätsmedizin Berlin, CVK
  • Universitätsklinikum Essen
  • Klinik für Neurologie, Klinische Neurophysiologie und Stroke Unit
  • Klinik und Poliklinik für Neurologie der Universität Regensburg im Bezirksklinikum
  • Evangelismos General Hospital
  • Agios Loukas (St. Luke's) Hospital
  • General Hospital of Thessaloniki "Papanikolaou"
  • Azienda Ospedaliero, Universitaria "Ospedali Riuniti", Clinica della Malattie del Sistema Nervoso, Università di Foggia
  • A.O.U Policlinico di Messina
  • Università degli Studi di Napoli Policlinico Federico II
  • Azienda Ospedaliero - Universitaria Maggiore della Carità
  • Istituto Neurologico Casimiro Mondino
  • Università Cattolica del Sacro Cuore Policlinico "A. Gemelli"
  • Azienda Universitatia Ospedaliera San Giovanni Battista
  • Centrum Neurologii Klinicznej
  • NZOZ Polimedica
  • Wojewódzki Szpital Specjalistyczny w Lublinie Oddzial Neurologii
  • Wojewódzki Szpital Specjalistyczny w Olsztynie, Oddzial Neurologii
  • NZOZ "NEURO - KARD,"Ilkowski I Partnerzy Spólka, Partnerska Lekarzy
  • Instytut Psychiatrii i Neurologii, II Klinika Neurologiczna

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

800 mg QD Eslicarbazepine acetate

1200 mg QD Eslicarbazepine acetate

Placebo

Arm Description

tablets

tablets

tablets

Outcomes

Primary Outcome Measures

Seizure Frequency Over the 12-week Maintenance Period.

Secondary Outcome Measures

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.

Full Information

First Posted
October 1, 2009
Last Updated
April 29, 2021
Sponsor
Bial - Portela C S.A.
Collaborators
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00988429
Brief Title
Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures
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 Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2, 2008 (undefined)
Primary Completion Date
January 12, 2012 (Actual)
Study Completion Date
January 12, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bial - Portela C S.A.
Collaborators
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Epilepsy
Keywords
Refractory, partial, epilepsy, efficacy, eslicarbazepine, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
653 (Actual)

8. Arms, Groups, and Interventions

Arm Title
800 mg QD Eslicarbazepine acetate
Arm Type
Active Comparator
Arm Description
tablets
Arm Title
1200 mg QD Eslicarbazepine acetate
Arm Type
Active Comparator
Arm Description
tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
tablets
Intervention Type
Drug
Intervention Name(s)
800 mg QD Eslicarbazepine acetate
Other Intervention Name(s)
BIA 2-093
Intervention Description
Oral, 800 mg QD, 2-week titration period and 12-week maintenance period
Intervention Type
Drug
Intervention Name(s)
1200 mg QD Eslicarbazepine acetate
Other Intervention Name(s)
BIA 2-093
Intervention Description
Oral, 1200 mg QD, 2-week titration followed by 12-week maintenance period
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pills
Intervention Description
Placebo tablet given QD
Primary Outcome Measure Information:
Title
Seizure Frequency Over the 12-week Maintenance Period.
Time Frame
12-week maintenance period (Week 3 to week 14)
Secondary Outcome Measure Information:
Title
Proportion of Responders
Description
Subjects who had at least a 50% reduction from baseline in standardized seizure frequency during the maintenance period were classified as responders.
Time Frame
Baseline (Week-8 through Week -1) and Maintenance period (Week 3 to week 14)

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
33338829
Citation
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.
Results Reference
derived
PubMed Identifier
32801102
Citation
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.
Results Reference
derived

Learn more about this trial

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

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