Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.

Study Overview

• Status: Completed
• Conditions: Epilepsy With Simple or Complex Partial Onset Seizures
• Intervention / Treatment: Drug: Eslicarbazepine acetate; Drug: Eslicarbazepine acetate

Detailed Description

This is an 18-week, double-blind, randomized, historical control, multicenter study with gradual conversion to monotherapy in subjects with partial onset seizures who are not well controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week period for titration of study drug, 6-week period for taper or conversion off AEDs, and a 10-week monotherapy period. Subjects not entering an optional open-label extension study will enter a 1-week period to taper off study drug followed by an end of study visit (week 19). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • London Health Sciences Center
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V2J2
      • Neuro-Epilepsy Clinic
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35234
      • Norwood Neurology
    • Birmingham, Alabama, United States, 35242
      • Greystone Neurology Center
    • Mobile, Alabama, United States, 36693
      • USA Neurology
    • Northport, Alabama, United States, 35476
      • Neurology Clinic, P.C.
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Xenoscience Inc.
    • Phoenix, Arizona, United States, 85003
      • Clinical Research Consortium
    • Phoenix, Arizona, United States, 85004
      • Clinical Research Consortium - Arizona
    • Sun City, Arizona, United States, 85351
      • Arizona Neurological Institute
    • Tucson, Arizona, United States, 85718
      • Center for Neurosciences
  • Arkansas
    • Little Rock, Arkansas, United States, 72201
      • K & S Professional Research Services
  • California
    • Berkley, California, United States, 94705
      • Sutter East Bay Medical Foundation
    • Escondido, California, United States, 92025
      • Synergy Escondido
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network
    • Loma Linda, California, United States, 92354
      • Loma Linda University
    • Loma Linda, California, United States, 92354
      • Faculty of Physicians & Surgeons of Loma Linda University
    • Los Gatos, California, United States, 95032
      • American Institute of Research
    • Northridge, California, United States, 91325
      • Northridge Neurological Center
    • Pasadena, California, United States, 91105
      • Yafa Minazad, DO
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Whittier, California, United States, 90603
      • American Institute of Research
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Anschutz Outpatient Pavilion
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Associated Neurologists, PC
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Inc.
    • Coral Gables, Florida, United States, 33134
      • Miami Clinical Research
    • Gulf Breeze, Florida, United States, 32561
      • NW FL Clinical Research Group, LLC
    • Hollywood, Florida, United States, 33021
      • Infiniti Clinical Research, LLC
    • Jacksonville, Florida, United States, 32209
      • University of Florida Health Science Center
    • Maitland, Florida, United States, 32751
      • Neurology Associates, PA
    • Melbourne, Florida, United States, 32901
      • MIMA Century Research Associates
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic
    • Miami, Florida, United States, 33176
      • Neurosciences Consultants, LLC
    • Orlando, Florida, United States, 32806
      • Neurological Services Orlando
    • Orlando, Florida, United States, 32819
      • Pediatric Neurolog, PA
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates of Ormond Beach
    • Port Charlotte, Florida, United States, 33952
      • Medsol Clinical Research Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
    • Tampa, Florida, United States, 33609
      • Pediatric Epilepsy & Neurology Specialists, PA
    • Tampa, Florida, United States, 33613
      • Florida Comprehensive Epilepsy and Seizure Disorder Center
    • Vero Beach, Florida, United States, 32960
      • Vero Neurology
    • Wellington, Florida, United States, 33414
      • Palm Beach Clinical Research Network LLC
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Peachtree Neurological Clinic
    • Atlanta, Georgia, United States, 30328
      • PANDA Neurology and Atlanta Headache Specialists
    • Atlanta, Georgia, United States, 30322
      • Emory University Department of Neurology
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
    • Suwanee, Georgia, United States, 30024
      • GA Neurology and Sleep Medicine Associates
  • Idaho
    • Boise, Idaho, United States, 83702
      • Consultants in Epilepsy and Neurology, PLLC.
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University
    • Chicago, Illinois, United States, 60637
      • UCMC
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • Bluegrass Epilepsy Research LLC
  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • North Oaks Neurology
  • Maine
    • Scarborough, Maine, United States, 04074
      • MMP Neurology
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins University
    • Bethesda, Maryland, United States, 20817
      • Mid-Atlantic Epilepsy and Sleep Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Epilepsy Service - WACC
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • The Comprehensive Epilepsy Care Center for Children and Adults
    • St. Louis, Missouri, United States, 63128
      • PsychCare Consultants Research
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Health System
    • Cherry Hill, New Jersey, United States, 08034
      • Cooper University Health System
    • Edison, New Jersey, United States, 08818
      • NJ Neuroscience Center
    • Livingston, New Jersey, United States, 07039
      • Institute of Neurology and Neurosurgery at St. Bamabas, Suite 101
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • University of Medicine and Dentistry of New Jersey
    • Paterson, New Jersey, United States, 07503
      • St. Joseph's Regional Medical Center
  • New York
    • Cedarhurst, New York, United States, 11516
      • Five Towns Neuroscience Research
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
    • New York, New York, United States, 10019
      • Clinilabs Inc.
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • The Neurology Institute
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
    • Winstom-Salem, North Carolina, United States, 27157
      • Wake Forest University
  • Ohio
    • Bellevue, Ohio, United States, 44811
      • Northern Ohio Neurosciences
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112'
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73112
      • 5929 N. May Ave.
  • Oregon
    • Medford, Oregon, United States, 97504
      • Providence Medical Group
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital Philadelphia
    • Pittsburg, Pennsylvania, United States, 15201
      • Children's Hospital of Pittsburg of UPMC
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Gus Stratton / Neurology
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Mid-South Physcians Group
    • Nashville, Tennessee, United States, 37203
      • Access Clinical Trials
    • Nashville, Tennessee, United States, 37232
      • VU Department of Neurology
  • Texas
    • Arlington, Texas, United States, 76017
      • Neurology Associates of Arlington, PA
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
    • Dallas, Texas, United States, 75230
      • Neurological Clinic of Texas P.A.
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77063
      • Todd Swick, MD, PA
    • Houston, Texas, United States, 77030
      • UT Health Science Center at Houston
    • Mansfield, Texas, United States, 76063
      • Neurology Associates of Arlington, PA
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Neurology Specialists
  • Washington
    • Bellevue, Washington, United States, 98004
      • Neurological Associates of Washington/Clinical Trials of America Inc.
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center, Inc.
    • Seattle, Washington, United States, 98144
      • Pacific Medical Centers
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of partial epilepsy as defined in the Classification of Seizures of the International League Against Epilepsy (ILAE) (simple partial seizures with observable motor component, or complex, with or without secondary generalization) a. Medical history of seizures; b. Absence of confounding factors (pseudoseizures, syncope); c. Documented EEG recording (done within 5 years prior to screening) consistent with focal onset epilepsy.
• Documented CT or MRI scan conducted within 10 years prior to screening, showing the absence of a progressive structural abnormality (eg, tumor). Mesial temporal sclerosis is acceptable.
• ≥4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure free period.
• Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening.
• Subjects must have the ability to comprehend the informed consent form and be willing to provide informed consent. For subjects who are unable to comprehend the written consent, a witness/caregiver who is able to describe and provide an understanding of the informed consent to the subject must sign the consent form on behalf of the subject.
• Subjects must give written informed consent prior to participation in the study. For subjects <18 years of age, the informed consent must be signed by the subject's parent or legal guardian, and, when appropriate and/or required by state or local law, minor subjects must give written informed assent prior to participation in the study. Subjects of Asian ancestry are required to give written informed consent for genotyping. All subjects must sign a HIPAA Form. All females of child bearing potential must also sign the "Women of Childbearing Potential" Addendum.
• A female subject is eligible to enter and participate in the study if she is of: a. Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is pre-menarchal or post-menopausal); b. Child-bearing potential (all females ≤65 years of age), has a negative pregnancy test at screening and agrees to satisfy contraception requirements.

Exclusion Criteria:

• Subjects with only simple partial seizures without a motor component.
• Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or Lennox-Gastaut syndrome).
• History of pseudo-seizures.
• Current seizures related to an acute medical illness.
• Seizures secondary to metabolic, toxic or infectious disorder or drug abuse.
• Status epilepticus within 2 years prior to screening.
• Seizures only occurring in a cluster pattern.
• Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin, carbamazepine, oxcarbazepine, or lamotrigine.
• Subjects taking 2 AEDs with both being in the upper dose range (defined as approximately two-thirds of the defined daily dose).
• Subjects taking more than 2 AEDs.
• Subjects with progressive structural central nervous system lesion or progressive encephalopathy.
• Psychiatric exclusion criteria: subjects with history of suicide attempt in last 2 years; major depressive episode within last 6 months; abuse of alcohol or substance abuse in last 2 years; significant psychiatric disorder or recurrent episodes of severe depression within 2 years prior to screening.
• Medical exclusion criteria: known renal insufficiency or subject with estimated creatinine clearance [CrCL] <60 mL/min based on serum creatinine using the Cockcroft-Gault formula.
• Clinical and laboratory exclusion criteria: Subjects of Asian ancestry who tests positive for the presence of the HLA-B*1502 allele.
• Subjects who have been on benzodiazepines, phenobarbital, or primidone on a regular basis within 3 months prior to screening.
• Subjects taking antipsychotics, tricyclic antidepressants, anxiolytics, sedative hypnotics including non-benzodiazepines, central opioid agonists/antagonists, monoamine oxidase inhibitors (MAOIs) within at least 5 half lives (or for at least 2 weeks whichever is longer) prior to randomization.
• Subjects presently on felbamate or vigabatrin
• Female subjects who are currently breastfeeding or intending to breastfeed during study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eslicarbazepine 1600 mg QD; Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg QD (Day 0) to 1200 mg QD (Week 1) to 1600 mg QD (Weeks 2-18) Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks.	Drug: Eslicarbazepine acetate; 1600 mg QD; Drug: Eslicarbazepine acetate; 1200 mg QD
Experimental: Eslicarbazepine 1200 mg QD; Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg QD (Day 0) to 800 mg QD (week 1) to 1200 mg QD (weeks 2-18) Subjects may continue in an open-label extension study with a starting dose of 1600 mg QD, or taper off study drug at the completion of this study The treatment period for subjects entering the open label extension study is up to 9 study visits over 18 weeks. The treatment period for subjects not entering the open-label extension study is up to 10 study visits over 19 weeks.	Drug: Eslicarbazepine acetate; 1600 mg QD; Drug: Eslicarbazepine acetate; 1200 mg QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative 112-day Exit Rate as Estimated by Kaplan-Meier Method	Cumulative exit rate was defined as the proportion of subjects meeting at least one of the five exit criteria over a 16-wk study period (start of Antiepilectic Drugs(AED) taper/conv.period (Wk 3 to end of double blind monotherapy period (Wk 18)):1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.	Week 3 to Week 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time on Eslicarbazepine Acetate Monotherapy.	The start of the monotherapy period was defined as the date of termination of all other AEDs while taking study monotherapy medication. Time on monotherapy was defined from the start of monotherapy period to the last dose of monotherapy treatment.	Week 8 to Week 18
Proportion (%) of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).		18 Week Double-blind treatment period
Percentage of Subjects That Are Seizure-free During the 10-week Double-blind Monotherapy Treatment Period.	Seizure-free subjects during the monotherapy period were determined as subjects who had seizure assessments during the monotherapy period, and did not have any seizures in the 10 weeks between Visits 6 and 9 (Weeks 9 through 18). Subjects who discontinued during this period were considered not seizure-free even if they were seizure-free at the time of discontinuation, i.e., to be considered seizure-free, subjects must complete the 10-week period without any seizures.	Weeks 9 through 18
Percentage of Subjects Seizure-free During the Last 4 Weeks on Eslicarbazepine Acetate Monotherapy.	Seizure-free subjects during the last four weeks of monotherapy were determined as subjects who had seizure assessments during the 4 weeks between Visits 8 and 9 (Weeks 15 through 18), and did not have any seizures.	Weeks 15 through 18
Completion Rate	Subjects completing the study were determined as subjects who completed the 18 weeks of double-blind treatment.	Week 1 to Week 18
Completion Rate During the 10 Weeks of Monotherapy	Monotherapy completion rate was defined as the proportion (%) of subjects entering the monotherapy period who completed the 10 weeks of monotherapy treatment.	Weeks 8 through 18
Change in Seizure Frequency From Baseline.	The relative (%) change in standardized seizure frequency was evaluated for four periods: titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).	Week 0 to Week 18, Double-blind: weeks 1to 18; baseline:weeks-8 to -1; Titration: weeks 1 to 2; AED taper/conversion:weeks 3 to 8; monotherapy: weeks 9 to 18
Responder Rate (Proportion [%] of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).	Responder rate was defined as the proportion (%) of subjects with a ≥ 50% reduction of seizure frequency from baseline. This analysis was done for the titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18) periods.	Week 0 to Week 18, Double blind: weeks to 8; baseline:weeks -8 to -1; titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; monotherapy: weeks 9 to 18
Percentage of Subjects Reaching Each of the Exit Events.	The percentage of subjects reaching each of the 5 exit criteria. 1.One episode of status epilepticus.2.One secondary general partial seizure (in subjects who did not have gen. seizures during 6 months prior to screening).3.A two fold increase in any consecutive 28 day seizure rate compared to the highest consecutive 28 day seizure rate during the 8 wk baseline period. 4.A two fold increase in any consecutive 2 day seizure rate compared to the highest consecutive 2 day seizure rate during the 8 wk baseline period. If the highest number of seizures in any consecutive 2 day period during the 8 wk baseline was 1 then 3 seizures in a consecutive 2 day period was required to exit.5.Worsening of seizures or increase in seizure frequency considered serious or requiring intervention as judged by the Investigator.	Week 1 to Week 18
Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).	The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.	Week 0 to Week 18, baseline: day 0: End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18
Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).	The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity	Week 0 to Week 18; Baseline: day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18
Change in Total Score From Baseline in MADRS in Those Subjects With a MADRS Score of ≥14 at Randomization.	The total score of MADRS is defined as the sum of all individual symptom scores, ranging from 0 to 60, higher score indicates more severe depression. Each of the 10 symptoms of depression on MADRS was measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity	Week 0 to Week 18, Baseline: Day 0; End of AED taper/conversion period: end of week 8; End of monotherapy period: end of week 18
Percentage of Subjects With Increase of Body Weight >= 7%		18 Week Double-blind treatment period
Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L	Proportion (%) of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L	18 Week Double-blind treatment period
Standardized Seizure Frequency (SSF) by Period	Seizure frequency was evaluated by using a standardized frequency per 4 weeks (28 days). It was evaluated for five periods: baseline (Weeks -8 to -1), titration (Weeks 1 to 2), AED taper/conversion (Weeks 3 to 8), monotherapy (Weeks 9 to 18), and double-blind (Weeks 1 to 18).	Week 1 to Week 18, Double-blind: weeks 1 to 18; Baseline: weeks -8 to -1; Titration: weeks 1 to 2; AED taper/conversion: weeks 3 to 8; Monotherapy: weeks 9 to 18

Collaborators and Investigators

• Sponsor: Sunovion

Publications and helpful links

General Publications

• Sperling MR, Harvey J, Grinnell T, Cheng H, Blum D; 045 Study Team. Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a randomized historical-control phase III study based in North America. Epilepsia. 2015 Apr;56(4):546-55. doi: 10.1111/epi.12934. Epub 2015 Feb 16. Erratum In: Epilepsia. 2016 Jul;57(7):1203.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 18, 2009
• First Submitted That Met QC Criteria: March 19, 2009
• First Posted (Estimate): March 20, 2009

Study Record Updates

• Last Update Posted (Estimate): March 11, 2016
• Last Update Submitted That Met QC Criteria: February 9, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Epilepsy; Monotherapy; Seizure; Anticonvulsant; Historical Control
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsies, Partial; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: 093-045