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Eslicarbazepine Acetate Monotherapy Long Term Study

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Eslicarbazepine acetate
Sponsored by
Sumitomo Pharma America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Seizures, Epilepsy, Anticonvulsant, Monotherapy, Epilepsy with simple or complete partial onset seizures

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Neurology Clinic, P.C.
  • 21st Century Neurology, a division of Xenoscience, Inc.
  • Clinical Research Consortium-Arizona
  • Arizona Neurological Institute
  • Center for Neurosciences
  • University of Arizona, Health Sciences Center
  • Arkansas Neurology
  • K&S Professional Research Services, LLC
  • Sutter East Bay Medical Foundation
  • Neuro-Pain Medical Center
  • Collaborative Neuroscience Network
  • Faculty of Physicians and Surgeons of Loma Linda University
  • Viking Clinical Research Center
  • Viking Clinical Research
  • Northridge Neurological Research Center
  • Yafa Minazad
  • Neurological Research Institute
  • Collaborative Neuroscience Network
  • Neurosearch II Inc
  • Neurosciences Clinic - University of Colorado Hospital
  • Denver Health
  • Associated Nuerologists, PC
  • JEM Research, LLC
  • Bradenton Clinical Research
  • Miami Research Inc.
  • NW FL Clinical Research Group, LLC
  • Palm Springs Research Institute
  • Infinity Clinical Research, LLC
  • Neurology Associates
  • San Marcus Research Clinic
  • Miami Children's Hospital
  • Neuroscience Consultants
  • Pediatric Neurology, PA
  • Neurology Associates of Ormond Beach
  • Bay Neurological Institute
  • Medsol Clinical Research Center
  • Pediatric Epilepsy & Neurology Specialists, PA
  • Palm Beach Clinical Research Network, LLC
  • PANDA Neurology and Atlanta Heachache Specialists
  • Harbin Clinic
  • Consultants in Epilepsy and Nuerology
  • OSF Saint Francis Medical Center
  • Southern Illinois University School of Medicine
  • Central DuPage Hospital
  • J.W.M. Neurology P.C.
  • McFarland Clinic, PC
  • University of Kansas Medical Center
  • Bluegrass Epilepsy Research, LLC
  • ECommunity Research LLC
  • MMP Neuroloy
  • Johns Hopkins University
  • Mid-Atlantic Epilepsy and Sleep Center
  • Brigham and Women's Hospital
  • Lahey Clinic
  • Wayne State University/Detroit Medical Center
  • Minneappolis Clinic of Neurology
  • Precise Research Centers
  • Comprehensive Epilepsy Care Center for Children and Adults
  • PsychCare Consultants Research
  • Northeast Regional Epilepsy Group
  • Jersey Shore University Medical Center
  • University Medicine and Dentistry of New Jersey
  • UMDNJ DOC 8th Floor 8100
  • Montefiore Medical Center
  • Five Towns Neuroscience Research
  • University of Rochester
  • SUNY Upstate Medical University
  • PMG Research of Hickory, LLC
  • Department of Neurology
  • Ohio Clinical Research Partners, LLC
  • The University of Toledo Health Science Campus
  • Lynn Health Science Institute
  • Sooner Clinical Research
  • Tulsa Clinical Research LLC
  • Children's Hospital of Philadelphia
  • Thomas Jefferson University
  • Temple University School of Medicine, Dept of Neurology
  • Children's Hospital of Pittsburgh of UPMC
  • Gus Stratton / Neurology
  • VU Department of Neurology
  • Neurology Associates of Arlington, P.A.
  • Edwin A Green, Jr., MD
  • Texas Neurology, PA
  • Neurological Clinic of Texas, P.A.
  • UT Health Science Center at Houston/ Dept of Neurology
  • MD
  • Neurology Associates of Arlington, P.A.
  • Innovative Clinical Trials
  • Road Runner Research
  • Scott and White Memorial Hospital
  • University of Utah Department of Neurology
  • Neurological Associates of Washington
  • Rainier Clinical Research Center Inc.
  • Pacific Medical Centers
  • West Virginia University
  • Regional Epilepsy Center
  • Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad
  • Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven
  • Second Multiprofile Hospital for Active Treatment
  • Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office
  • London Health Sciences Centre, University Campus
  • Neuro-Epilepsy Clinic/ Neuro Rive-Sud
  • Centre Hospitalier Universitaire de Sherbrooke
  • Policlinic Chocen, Private Neurology
  • Cerebrovaskularni poradna s.r.o
  • CTC Rychnov nad Kneznou
  • Evzen Nespor
  • Poradna pro epilepsie
  • Neurologicka ordinance
  • Clinic of Neurology, Clinical Center of Serbia
  • Institute of Mental Health, Department of epilepsy and clinical neurophysiology
  • 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
  • Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University
  • State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology
  • State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology
  • State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych
  • State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department
  • Communal Institution "Lviv Regional Clinical Psych Hospital"
  • Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care
  • Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev
  • Crimean Republican Institution "Clinical Psychiatric Hospital #1"
  • 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

eslicarbazepine acetate

Arm Description

Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD

Outcomes

Primary Outcome Measures

Number and Percent of Subjects With Treatment Emergent Adverse Events
Number and percent of subjects with treatment emergent adverse events

Secondary Outcome Measures

Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations
Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations
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.
Percentage of Subjects With Increase of Body Weight ≥7%
Percentage of subjects with increase of body weight ≥7%
Number and Percentage of Subjects With Orthostatic Effects.
Number and percentage of subjects with orthostatic effects.
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.
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.
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.
Change in Seizure Frequency From Baseline.
Relative (%) change in standard seizure frequency(SSF) 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).
Percentage of Subjects That Are Seizure-free During Study
Percentage of subjects that are seizure-free during study
Completion Rate (% of Subjects Completing the One Year Treatment)
Completion rate (% of subjects completing the one year treatment)
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.
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.
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.
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.
Completion Rate (% of Subjects Completing Each Visit Post-one Year).
Completion rate (% of subjects completing each visit post-one year).

Full Information

First Posted
May 27, 2009
Last Updated
July 16, 2018
Sponsor
Sumitomo Pharma America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00910247
Brief Title
Eslicarbazepine Acetate Monotherapy Long Term Study
Official Title
Long Term Eslicarbazepine Acetate Extension Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 15, 2017 (Actual)
Study Completion Date
April 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Seizures, Epilepsy, Anticonvulsant, Monotherapy, Epilepsy with simple or complete partial onset seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eslicarbazepine acetate
Arm Type
Experimental
Arm Description
Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD
Intervention Type
Drug
Intervention Name(s)
Eslicarbazepine acetate
Other Intervention Name(s)
SEP-0002093, BIA 2-093
Intervention Description
800 to 2400 mg once daily (QD)
Primary Outcome Measure Information:
Title
Number and Percent of Subjects With Treatment Emergent Adverse Events
Description
Number and percent of subjects with treatment emergent adverse events
Time Frame
One year
Secondary Outcome Measure Information:
Title
Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations
Description
Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations
Time Frame
1 year
Title
Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
Description
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.
Time Frame
1 year
Title
Percentage of Subjects With Increase of Body Weight ≥7%
Description
Percentage of subjects with increase of body weight ≥7%
Time Frame
1 year
Title
Number and Percentage of Subjects With Orthostatic Effects.
Description
Number and percentage of subjects with orthostatic effects.
Time Frame
1 year
Title
Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.
Description
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.
Time Frame
Baseline, Month 12
Title
Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).
Description
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.
Time Frame
1 year
Title
Time on Eslicarbazepine Acetate Monotherapy.
Description
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.
Time Frame
One year
Title
Change in Seizure Frequency From Baseline.
Description
Relative (%) change in standard seizure frequency(SSF) from baseline
Time Frame
Month 12 from baseline
Title
Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).
Description
Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).
Time Frame
One year
Title
Percentage of Subjects That Are Seizure-free During Study
Description
Percentage of subjects that are seizure-free during study
Time Frame
1 year
Title
Completion Rate (% of Subjects Completing the One Year Treatment)
Description
Completion rate (% of subjects completing the one year treatment)
Time Frame
One year
Title
Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)
Description
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.
Time Frame
One year
Title
Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).
Description
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.
Time Frame
baseline and Month 12
Title
Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).
Description
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.
Time Frame
1 year
Title
Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening
Description
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.
Time Frame
baseline and Month 12
Title
Completion Rate (% of Subjects Completing Each Visit Post-one Year).
Description
Completion rate (% of subjects completing each visit post-one year).
Time Frame
post 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CNS Medical Director
Organizational Affiliation
Sunovion Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Clinic, P.C.
City
Northport
State/Province
Alabama
ZIP/Postal Code
35476
Country
United States
Facility Name
21st Century Neurology, a division of Xenoscience, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Clinical Research Consortium-Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Arizona Neurological Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Center for Neurosciences
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Facility Name
University of Arizona, Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Neurology
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
Country
United States
Facility Name
K&S Professional Research Services, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Sutter East Bay Medical Foundation
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Faculty of Physicians and Surgeons of Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Viking Clinical Research Center
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Viking Clinical Research
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Northridge Neurological Research Center
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Yafa Minazad
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Neurological Research Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Neurosearch II Inc
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Neurosciences Clinic - University of Colorado Hospital
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
Associated Nuerologists, PC
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
JEM Research, LLC
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Bradenton Clinical Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Miami Research Inc.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
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
Infinity Clinical Research, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Neurology Associates
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
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
Pediatric Neurology, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Neurology Associates of Ormond Beach
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Bay Neurological Institute
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Medsol Clinical Research Center
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Pediatric Epilepsy & Neurology Specialists, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
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
PANDA Neurology and Atlanta Heachache Specialists
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
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 Nuerology
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
J.W.M. 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
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Bluegrass Epilepsy Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
ECommunity Research LLC
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
Country
United States
Facility Name
MMP Neuroloy
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04704
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 Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
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
Minneappolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Comprehensive Epilepsy Care Center for Children and Adults
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
PsychCare Consultants Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
University Medicine and Dentistry of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
UMDNJ DOC 8th Floor 8100
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
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
University of Rochester
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
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Department of Neurology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Ohio Clinical Research Partners, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
The 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
Sooner Clinical Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Tulsa Clinical Research LLC
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
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University School of Medicine, Dept of Neurology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15201
Country
United States
Facility Name
Gus Stratton / Neurology
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
VU Department of Neurology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Neurology Associates of Arlington, P.A.
City
Arlington
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Edwin A Green, Jr., MD
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
Neurological Clinic of Texas, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
UT Health Science Center at Houston/ Dept of Neurology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States
Facility Name
Neurology Associates of Arlington, P.A.
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063
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
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Utah Department of Neurology
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Neurological Associates of Washington
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Rainier Clinical Research Center Inc.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Pacific Medical Centers
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Regional Epilepsy Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Second Multiprofile Hospital for Active Treatment
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
London Health Sciences Centre, University Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Neuro-Epilepsy Clinic/ Neuro Rive-Sud
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Policlinic Chocen, Private Neurology
City
Smetanova Lhota
State/Province
Chocen
ZIP/Postal Code
56501
Country
Czechia
Facility Name
Cerebrovaskularni poradna s.r.o
City
Třebovice
State/Province
Ostrava
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
CTC Rychnov nad Kneznou
City
Rychnov nad Kneznou
State/Province
Praugue
ZIP/Postal Code
516 01
Country
Czechia
Facility Name
Evzen Nespor
City
Praha
State/Province
Strasnice
Country
Czechia
Facility Name
Poradna pro epilepsie
City
Koty
State/Province
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Neurologicka ordinance
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Clinic of Neurology, Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Institute of Mental Health, Department of epilepsy and clinical neurophysiology
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
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
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology
City
Kharkov
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych
City
Kharkov
ZIP/Postal Code
61153
Country
Ukraine
Facility Name
State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department
City
Kiev
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Communal Institution "Lviv Regional Clinical Psych Hospital"
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine
Facility Name
Crimean Republican Institution "Clinical Psychiatric Hospital #1"
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
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
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

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Eslicarbazepine Acetate Monotherapy Long Term Study

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