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EpilepsyPhase 3NCT00910247

Eslicarbazepine Acetate Monotherapy Long Term Study

A Phase 3 study testing Eslicarbazepine acetate in people with Epilepsy, run by Sumitomo Pharma America, Inc. at 122 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Epilepsy
What is being tested?
Eslicarbazepine acetate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
274 participants
Where
122 sitesin 6 countries
Study dates
Aug 2009to 15 Apr 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

122 sites in 6 countries.

122 sites in 6 countries

United States96 sites

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • Neurology Associates of Arlington, P.A.

    Arlington, Texas, 76107

  • PANDA Neurology and Atlanta Heachache Specialists

    Atlanta, Georgia, 30328

  • JEM Research, LLC

    Atlantis, Florida, 33462

  • Neurosciences Clinic - University of Colorado Hospital

    Aurora, Colorado, 80045

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Neurological Associates of Washington

    Bellevue, Washington, 98004

  • Sutter East Bay Medical Foundation

    Berkeley, California, 94705

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817

  • Consultants in Epilepsy and Nuerology

    Boise, Idaho, 83702

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bradenton Clinical Research

    Bradenton, Florida, 34205

  • Edwin A Green, Jr., MD

    Brownwood, Texas, 76801

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • Ohio Clinical Research Partners, LLC

    Canton, Ohio, 44718

  • Five Towns Neuroscience Research

    Cedarhurst, New York, 11516

  • Comprehensive Epilepsy Care Center for Children and Adults

    Chesterfield, Missouri, 63017

  • Arkansas Neurology

    Conway, Arkansas, 72034

  • Miami Research Inc.

    Coral Gables, Florida, 33134

  • Gus Stratton / Neurology

    Cranston, Rhode Island, 02920

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • Neurological Clinic of Texas, P.A.

    Dallas, Texas, 75230

  • Associated Nuerologists, PC

    Danbury, Connecticut, 06810

  • Denver Health

    Denver, Colorado, 80204

  • Wayne State University/Detroit Medical Center

    Detroit, Michigan, 48201

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Neuro-Pain Medical Center

    Fresno, California, 93710

  • Collaborative Neuroscience Network

    Garden Grove, California, 92845

  • Minneappolis Clinic of Neurology

    Golden Valley, Minnesota, 55422

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey, 07601

  • ECommunity Research LLC

    Hammond, Louisiana, 70403

  • Palm Springs Research Institute

    Hialeah, Florida, 33012

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602

  • Infinity Clinical Research, LLC

    Hollywood, Florida, 33021

  • UT Health Science Center at Houston/ Dept of Neurology

    Houston, Texas, 77030

  • MD

    Houston, Texas, 77063

  • J.W.M. Neurology P.C.

    Indianapolis, Indiana, 46237

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Bluegrass Epilepsy Research, LLC

    Lexington, Kentucky, 40504

  • K&S Professional Research Services, LLC

    Little Rock, Arkansas, 72201

  • Faculty of Physicians and Surgeons of Loma Linda University

    Loma Linda, California, 92354

  • Neurology Associates

    Maitland, Florida, 32751

  • Neurology Associates of Arlington, P.A.

    Mansfield, Texas, 76063

  • San Marcus Research Clinic

    Miami, Florida, 33015

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Neuroscience Consultants

    Miami, Florida, 33176

  • Regional Epilepsy Center

    Milwaukee, Wisconsin, 53215

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Viking Clinical Research Center

    Murrieta, California, 92562

  • Viking Clinical Research

    Murrieta, California, 92562

  • VU Department of Neurology

    Nashville, Tennessee, 37232

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • University Medicine and Dentistry of New Jersey

    New Brunswick, New Jersey, 08901

  • UMDNJ DOC 8th Floor 8100

    Newark, New Jersey, 07103

  • Neurology Clinic, P.C.

    Northport, Alabama, 35476

  • Northridge Neurological Research Center

    Northridge, California, 91325

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Sooner Clinical Research

    Oklahoma City, Oklahoma, 73112

  • Pediatric Neurology, PA

    Orlando, Florida, 32819

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Bay Neurological Institute

    Panama City, Florida, 32405

  • Yafa Minazad

    Pasadena, California, 91105

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University School of Medicine, Dept of Neurology

    Philadelphia, Pennsylvania, 19140

  • 21st Century Neurology, a division of Xenoscience, Inc.

    Phoenix, Arizona, 85004

  • Clinical Research Consortium-Arizona

    Phoenix, Arizona, 85004

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15201

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952

  • Rainier Clinical Research Center Inc.

    Renton, Washington, 98057

  • University of Rochester

    Rochester, New York, 14642

  • Harbin Clinic

    Rome, Georgia, 30165

  • University of Utah Department of Neurology

    Salt Lake City, Utah, 84132

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Road Runner Research

    San Antonio, Texas, 78258

  • Neurological Research Institute

    Santa Monica, California, 90404

  • MMP Neuroloy

    Scarborough, Maine, 04704

  • Pacific Medical Centers

    Seattle, Washington, 98144

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Arizona Neurological Institute

    Sun City, Arizona, 85351

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Pediatric Epilepsy & Neurology Specialists, PA

    Tampa, Florida, 33609

  • Scott and White Memorial Hospital

    Temple, Texas, 76508

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • The University of Toledo Health Science Campus

    Toledo, Ohio, 43614

  • Collaborative Neuroscience Network

    Torrance, California, 90502

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • University of Arizona, Health Sciences Center

    Tucson, Arizona, 85724

  • Tulsa Clinical Research LLC

    Tulsa, Oklahoma, 74104

  • Neurosearch II Inc

    Ventura, California, 93003

  • Palm Beach Clinical Research Network, LLC

    Wellington, Florida, 33414

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Department of Neurology

    Winston-Salem, North Carolina, 27517

Other trials in United States

Ukraine11 sites

  • 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

    Dnipropetrovsk, 49005

  • Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University

    Donetsk, 83008

  • State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology

    Kharkiv, 61018

  • State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology

    Kharkiv, 61068

  • State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych

    Kharkiv, 61153

  • State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department

    Kiev, 01030

  • Communal Institution "Lviv Regional Clinical Psych Hospital"

    Lviv, 79021

  • Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care

    Odesa, 65006

  • Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev

    Poltava, 36006

  • Crimean Republican Institution "Clinical Psychiatric Hospital #1"

    Simferopol, 95006

  • 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

    Vinnytsia, 21005

Other trials in Ukraine

Czechia6 sites

  • Poradna pro epilepsie

    Koty, Zlín, 760 01

  • Evzen Nespor

    Prague, Strasnice

  • Neurologicka ordinance

    Prague, 160 00

  • CTC Rychnov nad Kneznou

    Rychnov nad Kněžnou, Praugue, 516 01

  • Policlinic Chocen, Private Neurology

    Smetanova Lhota, Chocen, 56501

  • Cerebrovaskularni poradna s.r.o

    Třebovice, Ostrava, 722 00

Other trials in Czechia

Bulgaria4 sites

  • Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad

    Blagoevgrad, 2700

  • Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven

    Pleven, 5800

  • Second Multiprofile Hospital for Active Treatment

    Sofia, 1202

  • Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office

    Varna, 9000

Other trials in Bulgaria

Canada3 sites

  • Neuro-Epilepsy Clinic/ Neuro Rive-Sud

    Greenfield Park, Quebec, J4V 2J2

  • London Health Sciences Centre, University Campus

    London, Ontario, N6A 5A5

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Serbia2 sites

  • Clinic of Neurology, Clinical Center of Serbia

    Belgrade, 11 000

  • Institute of Mental Health, Department of epilepsy and clinical neurophysiology

    Belgrade, 11 000

Other trials in Serbia

About this study

Official title: Long Term Eslicarbazepine Acetate Extension Study

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

Read the 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.

Conditions
Epilepsy
Being tested
Eslicarbazepine acetate
Keywords
Seizures, Epilepsy, Anticonvulsant, Monotherapy, Epilepsy with simple or complete partial onset seizures
Medical subject headings
Epilepsy, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eslicarbazepine acetateDrug

    Also called SEP-0002093, BIA 2-093

    800 to 2400 mg once daily (QD)

Study groups in NCT00910247
Study groupRoleWhat they receive
eslicarbazepine acetateExperimentalOpen-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD
Receives: Drug: Eslicarbazepine acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Percent of Subjects With Treatment Emergent Adverse Events

    Number and percent of subjects with treatment emergent adverse events

    Measured: One year

Secondary outcomes (16)

  1. Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations

    Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. Percentage of Subjects With Increase of Body Weight ≥7%

    Percentage of subjects with increase of body weight ≥7%

    Measured: 1 year

  4. Number and Percentage of Subjects With Orthostatic Effects.

    Number and percentage of subjects with orthostatic effects.

    Measured: 1 year

  5. 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:

    1. >500 millisecond (msec) at any post-baseline timepoint but not present at baseline
    2. >480 msec at any post-baseline timepoint but not present at baseline
    3. >450 msec at any post-baseline timepoint but not present at baseline
    4. Change from Baseline >=60 ms for at least one post-baseline measurement
    5. 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.

    Measured: Baseline, Month 12

  6. 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.

    Measured: 1 year

  7. 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.

    Measured: One year

  8. Change in Seizure Frequency From Baseline.

    Relative (%) change in standard seizure frequency(SSF) from baseline

    Measured: Month 12 from baseline

  9. 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).

    Measured: One year

  10. Percentage of Subjects That Are Seizure-free During Study

    Percentage of subjects that are seizure-free during study

    Measured: 1 year

  11. Completion Rate (% of Subjects Completing the One Year Treatment)

    Completion rate (% of subjects completing the one year treatment)

    Measured: One year

  12. 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.

    Measured: One year

  13. 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.

    Measured: baseline and Month 12

  14. 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.

    Measured: 1 year

  15. 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.

    Measured: baseline and Month 12

  16. Completion Rate (% of Subjects Completing Each Visit Post-one Year).

    Completion rate (% of subjects completing each visit post-one year).

    Measured: post 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2009 (estimated)
  2. Study startAug 2009
  3. Primary completion15 Apr 2017
  4. Study completion15 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910247
Sponsor's protocol ID
093-050
Status last verified
Jul 2018
First submitted
27 May 2009
Last updated
17 Jul 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eslicarbazepine acetate in people with Epilepsy, run by Sumitomo Pharma America, Inc. at 122 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 122 sites in United States, Ukraine, Czechia, Bulgaria, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percent of Subjects With Treatment Emergent Adverse Events (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910247.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018; AzTrials last refreshed its copy on 29 Oct 2026.

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