Eslicarbazepine Acetate Monotherapy Long Term Study

Long Term Eslicarbazepine Acetate Extension Study

This is a long term, open-label, safety extension study in subjects with partial onset seizures.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: Eslicarbazepine acetate

Detailed Description

This is a long term, multicenter, open-label, safety extension study in subjects with partial onset seizures who have just completed, discontinued, or exited the 18-week treatment phase of Protocols 093-045 or 093-046. The initial study duration is 1 year with the option of continuing study drug treatment post 1 year until a subject discontinues study, the study drug becomes clinically available in the subject's locale, or the sponsor terminates the study drug clinical development program.

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): 274
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad
  • Pleven, Bulgaria, 5800
    • Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven
  • Sofia, Bulgaria, 1202
    • Second Multiprofile Hospital for Active Treatment
  • Varna, Bulgaria, 9000
    • Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Campus
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Neuro-Epilepsy Clinic/ Neuro Rive-Sud
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke
• Czechia
  • Praha 6, Czechia, 160 00
    • Neurologicka ordinance
  • Chocen
    • Smetanova Lhota, Chocen, Czechia, 56501
      • Policlinic Chocen, Private Neurology
  • Ostrava
    • Třebovice, Ostrava, Czechia, 722 00
      • Cerebrovaskularni poradna s.r.o
  • Praugue
    • Rychnov nad Kneznou, Praugue, Czechia, 516 01
      • CTC Rychnov nad Kneznou
  • Strasnice
    • Praha, Strasnice, Czechia
      • Evzen Nespor
  • Zlin
    • Koty, Zlin, Czechia, 760 01
      • Poradna pro epilepsie
• Serbia
  • Belgrade, Serbia, 11 000
    • Clinic of Neurology, Clinical Center of Serbia
  • Belgrade, Serbia, 11 000
    • Institute of Mental Health, Department of epilepsy and clinical neurophysiology
• Ukraine
  • Dnipropetrovsk, Ukraine, 49005
    • Communal Institution "Dnipropetrovsk Regional Clinical Hospital named after l.l. Mechnikov" Regional Center of psychosomatic disorders, Psychoneurology department for patients with psychosomatic disorders and borderline conditions
  • Donetsk, Ukraine, 83008
    • Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University
  • Kharkiv, Ukraine, 61068
    • State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology
  • Kharkov, Ukraine, 61018
    • State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology
  • Kharkov, Ukraine, 61153
    • State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych
  • Kiev, Ukraine, 01030
    • State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department
  • Lviv, Ukraine, 79021
    • Communal Institution "Lviv Regional Clinical Psych Hospital"
  • Odessa, Ukraine, 65006
    • Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care
  • Poltava, Ukraine, 36006
    • Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev
  • Simferopol, Ukraine, 95006
    • Crimean Republican Institution "Clinical Psychiatric Hospital #1"
  • Vinnytsia, Ukraine, 21005
    • Communal Institution "Vinnystsia Regional Psycho-Neurological Hospital named after O.I. Yuschenko, Vinnytsia National Medical University named after M.I. Pirogov, Dispensary department, Department of Psychiatry and Addictology
• United States
  • Alabama
    • Northport, Alabama, United States, 35476
      • Neurology Clinic, P.C.
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • 21st Century Neurology, a Division of Xenoscience, Inc.
    • 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
    • Tucson, Arizona, United States, 85724
      • University of Arizona, Health Sciences Center
  • Arkansas
    • Conway, Arkansas, United States, 72034
      • Arkansas Neurology
    • Little Rock, Arkansas, United States, 72201
      • K&S Professional Research Services, LLC
  • California
    • Berkeley, California, United States, 94705
      • Sutter East Bay Medical Foundation
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Network
    • Loma Linda, California, United States, 92354
      • Faculty of Physicians and Surgeons of Loma Linda University
    • Murrieta, California, United States, 92562
      • Viking Clinical Research Center
    • Murrieta, California, United States, 92562
      • Viking Clinical Research
    • Northridge, California, United States, 91325
      • Northridge Neurological Research Center
    • Pasadena, California, United States, 91105
      • Yafa Minazad
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Torrance, California, United States, 90502
      • Collaborative Neuroscience Network
    • Ventura, California, United States, 93003
      • Neurosearch II Inc
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Neurosciences Clinic - University of Colorado Hospital
    • Denver, Colorado, United States, 80204
      • Denver Health
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Associated Nuerologists, PC
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research, LLC
    • Bradenton, Florida, United States, 34205
      • Bradenton Clinical Research
    • Coral Gables, Florida, United States, 33134
      • Miami Research Inc.
    • Gulf Breeze, Florida, United States, 32561
      • NW FL Clinical Research Group, LLC
    • Hialeah, Florida, United States, 33012
      • Palm Springs Research Institute
    • Hollywood, Florida, United States, 33021
      • Infinity Clinical Research, LLC
    • Maitland, Florida, United States, 32751
      • Neurology Associates
    • Miami, Florida, United States, 33155
      • Miami Children's Hospital
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic
    • Miami, Florida, United States, 33176
      • Neuroscience Consultants
    • Orlando, Florida, United States, 32819
      • Pediatric Neurology, PA
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates of Ormond Beach
    • Panama City, Florida, United States, 32405
      • Bay Neurological Institute
    • Port Charlotte, Florida, United States, 33952
      • Medsol Clinical Research Center
    • Tampa, Florida, United States, 33609
      • Pediatric Epilepsy & Neurology Specialists, PA
    • Wellington, Florida, United States, 33414
      • Palm Beach Clinical Research Network, LLC
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • PANDA Neurology and Atlanta Heachache Specialists
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
  • Idaho
    • Boise, Idaho, United States, 83702
      • Consultants in Epilepsy and Nuerology
  • Illinois
    • Peoria, Illinois, United States, 61637
      • OSF Saint Francis Medical Center
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University School of Medicine
    • Winfield, Illinois, United States, 60190
      • Central DuPage Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • J.W.M. Neurology P.C.
  • 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
      • ECommunity Research LLC
  • Maine
    • Scarborough, Maine, United States, 04704
      • MMP Neuroloy
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
    • Bethesda, Maryland, United States, 20817
      • Mid-Atlantic Epilepsy and Sleep Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University/Detroit Medical Center
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneappolis Clinic of Neurology
  • Mississippi
    • Flowood, Mississippi, United States, 39232
      • Precise Research Centers
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Comprehensive Epilepsy Care Center for Children and Adults
    • Saint Louis, Missouri, United States, 63128
      • PsychCare Consultants Research
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Northeast Regional Epilepsy Group
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • New Brunswick, New Jersey, United States, 08901
      • University Medicine and Dentistry of New Jersey
    • Newark, New Jersey, United States, 07103
      • UMDNJ DOC 8th Floor 8100
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Cedarhurst, New York, United States, 11516
      • Five Towns Neuroscience Research
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • PMG Research of Hickory, LLC
    • Winston-Salem, North Carolina, United States, 27517
      • Department of Neurology
  • Ohio
    • Canton, Ohio, United States, 44718
      • Ohio Clinical Research Partners, LLC
    • Toledo, Ohio, United States, 43614
      • The University of Toledo Health Science Campus
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73112
      • Sooner Clinical Research
    • Tulsa, Oklahoma, United States, 74104
      • Tulsa Clinical Research LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University School of Medicine, Dept of Neurology
    • Pittsburgh, Pennsylvania, United States, 15201
      • Children's Hospital of Pittsburgh of UPMC
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Gus Stratton / Neurology
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • VU Department of Neurology
  • Texas
    • Arlington, Texas, United States, 76107
      • Neurology Associates of Arlington, P.A.
    • Brownwood, Texas, United States, 76801
      • Edwin A Green, Jr., MD
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
    • Dallas, Texas, United States, 75230
      • Neurological Clinic of Texas, P.A.
    • Houston, Texas, United States, 77030
      • UT Health Science Center at Houston/ Dept of Neurology
    • Houston, Texas, United States, 77063
      • MD
    • Mansfield, Texas, United States, 76063
      • Neurology Associates of Arlington, P.A.
    • San Antonio, Texas, United States, 78258
      • Road Runner Research
    • San Antonio, Texas, United States, 78229
      • Innovative Clinical Trials
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Department of Neurology
  • Washington
    • Bellevue, Washington, United States, 98004
      • Neurological Associates of Washington
    • 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
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Regional Epilepsy Center

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

Subject Inclusion/Exclusion Criteria:

• Subject who completed, exited, or discontinued for reasons other than safety from the 18-week treatment phase of Protocols 093-045 or 093-046 and are willing to continue participation in this study are eligible. Subject must have completed at least the first 3 weeks of the 18-week double-blind treatment period of Protocols 093-045 or 093-046 to be eligible.
• Subject 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. All subjects must sign privacy authorization form, if applicable. All females of child bearing potential (≤65 years of age) must also sign the "Women of Childbearing Potential" Addendum.
• Subjects must, in the opinion of the Investigator (with consultation with Medical Monitor as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.
• If female subject, must continue the accepted method of birth control defined in Protocols 093-045 or 093-046 for the duration of this study as well
• Criterion for Continuation into the Post 1 year Part of Study:

For subjects to continue into the post 1 year part of the study, subjects must, in the opinion of the Investigator (with consultation with Medical Monitor, as appropriate), continue to potentially benefit from continued study participation and have no new medical conditions that would preclude study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eslicarbazepine acetate; Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD	Drug: Eslicarbazepine acetate; 800 to 2400 mg once daily (QD); Other Names: SEP-0002093; BIA 2-093

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percent of Subjects With Treatment Emergent Adverse Events	Number and percent of subjects with treatment emergent adverse events	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations	Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations	1 year
Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L	Number and percentage of subjects who had normal sodium value (i.e. >135 mEq/L) at baseline but reached <=135 mEq/L and >130 mEq/L, <=130 mEq/L and >125 mEq/L, or <=125 mEq/L at any post baseline.	1 year
Percentage of Subjects With Increase of Body Weight ≥7%	Percentage of subjects with increase of body weight ≥7%	1 year
Number and Percentage of Subjects With Orthostatic Effects.	Number and percentage of subjects with orthostatic effects.	1 year
Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.	Number and percentage of subjects by QT interval corrected using the Fridericia fomula (QTcF) categories Based on the numbers of subjects who had at least one post-baseline assessment, the number and percentage of subjects with QTcF values in the following categories were summarized: >500 millisecond (msec) at any post-baseline timepoint but not present at baseline; >480 msec at any post-baseline timepoint but not present at baseline; >450 msec at any post-baseline timepoint but not present at baseline; Change from Baseline >=60 ms for at least one post-baseline measurement; Change from Baseline >=30 ms for at least one post-baseline measurement and <60 ms for all post-baseline measurement QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.	Baseline, Month 12
Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).	The C-SSRS is an instrument designed to systematically assess and track suicidal behavior and suicidal ideation. The C-SSRS will be completed by the Investigator or Sub-Investigator (or qualified site personnel). Suicidal ideation is collected as any occurrence of wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with specific plan and intent. Suicidal behavior is collected as any occurrence of actual attempts, Non-Suicidal Self-Injurious Behavior, interrupted attempts, aborted attempts, or preparatory acts or behavior, suicidal behavior. Any suicidality is defined as having at least one occurrence of Suicidal Behavior or Suicidal Ideation.	1 year
Time on Eslicarbazepine Acetate Monotherapy.	The start of the monotherapy period was defined as the date of termination of all other anti-epileptic drugs while taking study medication. Time on eslicarbazepine acetate monotherapy is defined from the date of the first monotherapy dose in 093-045 or 093-046 study to the last known dose of monotherapy treatment, regardless of dose change and the time gap between the parent studies and the current study.	One year
Change in Seizure Frequency From Baseline.	Relative (%) change in standard seizure frequency(SSF) from baseline	Month 12 from baseline
Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).	Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).	One year
Percentage of Subjects That Are Seizure-free During Study	Percentage of subjects that are seizure-free during study	1 year
Completion Rate (% of Subjects Completing the One Year Treatment)	Completion rate (% of subjects completing the one year treatment)	One year
Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)	The retention time is defined from the start of eslicarbazepine acetate monotherapy period in 093-045 or 093-046 to the last known dose of open-label eslicarbazepine acetate. The time may include taking eslicarbazepine acetate concomitantly with other anti-epileptic drugs. If a subject's termination reason(s) includes: withdrawal of consent, lost to follow-up, physician decision or other, then it was assumed the subject terminated the study due to lack of efficacy.	One year
Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).	Change in the overall 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.	baseline and Month 12
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 item scores. Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.	1 year
Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening	The total score of MADRS is defined as the sum of all individual item scores . Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.	baseline and Month 12
Completion Rate (% of Subjects Completing Each Visit Post-one Year).	Completion rate (% of subjects completing each visit post-one year).	post 1 year

Collaborators and Investigators

• Sponsor: Sunovion
• Investigators: Study Director: CNS Medical Director, Sunovion Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): April 15, 2017
• Study Completion (Actual): April 15, 2017

Study Registration Dates

• First Submitted: May 27, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 16, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Epilepsy; Seizures; Monotherapy; Anticonvulsant; Epilepsy with simple or complete partial onset seizures
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Eslicarbazepine acetate
• Other Study ID Numbers: 093-050