Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
274 participants
INTERVENTIONAL
2009-08-31
2017-04-15
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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eslicarbazepine acetate
Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD
Eslicarbazepine acetate
800 to 2400 mg once daily (QD)
Interventions
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Eslicarbazepine acetate
800 to 2400 mg once daily (QD)
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
* 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.
16 Years
70 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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CNS Medical Director
Role: STUDY_DIRECTOR
Sunovion Pharmaceuticals
Locations
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Neurology Clinic, P.C.
Northport, Alabama, United States
21st Century Neurology, a division of Xenoscience, Inc.
Phoenix, Arizona, United States
Clinical Research Consortium-Arizona
Phoenix, Arizona, United States
Arizona Neurological Institute
Sun City, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
University of Arizona, Health Sciences Center
Tucson, Arizona, United States
Arkansas Neurology
Conway, Arkansas, United States
K&S Professional Research Services, LLC
Little Rock, Arkansas, United States
Sutter East Bay Medical Foundation
Berkeley, California, United States
Neuro-Pain Medical Center
Fresno, California, United States
Collaborative Neuroscience Network
Garden Grove, California, United States
Faculty of Physicians and Surgeons of Loma Linda University
Loma Linda, California, United States
Viking Clinical Research Center
Murrieta, California, United States
Viking Clinical Research
Murrieta, California, United States
Northridge Neurological Research Center
Northridge, California, United States
Yafa Minazad
Pasadena, California, United States
Neurological Research Institute
Santa Monica, California, United States
Collaborative Neuroscience Network
Torrance, California, United States
Neurosearch II Inc
Ventura, California, United States
Neurosciences Clinic - University of Colorado Hospital
Aurora, Colorado, United States
Denver Health
Denver, Colorado, United States
Associated Nuerologists, PC
Danbury, Connecticut, United States
JEM Research, LLC
Atlantis, Florida, United States
Bradenton Clinical Research
Bradenton, Florida, United States
Miami Research Inc.
Coral Gables, Florida, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
Palm Springs Research Institute
Hialeah, Florida, United States
Infinity Clinical Research, LLC
Hollywood, Florida, United States
Neurology Associates
Maitland, Florida, United States
San Marcus Research Clinic
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Neuroscience Consultants
Miami, Florida, United States
Pediatric Neurology, PA
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Bay Neurological Institute
Panama City, Florida, United States
Medsol Clinical Research Center
Port Charlotte, Florida, United States
Pediatric Epilepsy & Neurology Specialists, PA
Tampa, Florida, United States
Palm Beach Clinical Research Network, LLC
Wellington, Florida, United States
PANDA Neurology and Atlanta Heachache Specialists
Atlanta, Georgia, United States
Harbin Clinic
Rome, Georgia, United States
Consultants in Epilepsy and Nuerology
Boise, Idaho, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Central DuPage Hospital
Winfield, Illinois, United States
J.W.M. Neurology P.C.
Indianapolis, Indiana, United States
McFarland Clinic, PC
Ames, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, United States
ECommunity Research LLC
Hammond, Louisiana, United States
MMP Neuroloy
Scarborough, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
Wayne State University/Detroit Medical Center
Detroit, Michigan, United States
Minneappolis Clinic of Neurology
Golden Valley, Minnesota, United States
Precise Research Centers
Flowood, Mississippi, United States
Comprehensive Epilepsy Care Center for Children and Adults
Chesterfield, Missouri, United States
PsychCare Consultants Research
St Louis, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
University Medicine and Dentistry of New Jersey
New Brunswick, New Jersey, United States
UMDNJ DOC 8th Floor 8100
Newark, New Jersey, United States
Five Towns Neuroscience Research
Cedarhurst, New York, United States
University of Rochester
Rochester, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Department of Neurology
Winston-Salem, North Carolina, United States
Ohio Clinical Research Partners, LLC
Canton, Ohio, United States
The University of Toledo Health Science Campus
Toledo, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Tulsa Clinical Research LLC
Tulsa, Oklahoma, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University School of Medicine, Dept of Neurology
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
Gus Stratton / Neurology
Cranston, Rhode Island, United States
VU Department of Neurology
Nashville, Tennessee, United States
Neurology Associates of Arlington, P.A.
Arlington, Texas, United States
Edwin A Green, Jr., MD
Brownwood, Texas, United States
Texas Neurology, PA
Dallas, Texas, United States
Neurological Clinic of Texas, P.A.
Dallas, Texas, United States
UT Health Science Center at Houston/ Dept of Neurology
Houston, Texas, United States
MD
Houston, Texas, United States
Neurology Associates of Arlington, P.A.
Mansfield, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Road Runner Research
San Antonio, Texas, United States
Scott and White Memorial Hospital
Temple, Texas, United States
University of Utah Department of Neurology
Salt Lake City, Utah, United States
Neurological Associates of Washington
Bellevue, Washington, United States
Rainier Clinical Research Center Inc.
Renton, Washington, United States
Pacific Medical Centers
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
Regional Epilepsy Center
Milwaukee, Wisconsin, United States
Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad
Blagoevgrad, , Bulgaria
Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven
Pleven, , Bulgaria
Second Multiprofile Hospital for Active Treatment
Sofia, , Bulgaria
Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office
Varna, , Bulgaria
London Health Sciences Centre, University Campus
London, Ontario, Canada
Neuro-Epilepsy Clinic/ Neuro Rive-Sud
Greenfield Park, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Policlinic Chocen, Private Neurology
Smetanova Lhota, Chocen, Czechia
Cerebrovaskularni poradna s.r.o
Třebovice, Ostrava, Czechia
CTC Rychnov nad Kneznou
Rychnov nad Kněžnou, Praugue, Czechia
Evzen Nespor
Prague, Strasnice, Czechia
Poradna pro epilepsie
Koty, Zlín, Czechia
Neurologicka ordinance
Prague, , Czechia
Clinic of Neurology, Clinical Center of Serbia
Belgrade, , Serbia
Institute of Mental Health, Department of epilepsy and clinical neurophysiology
Belgrade, , Serbia
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, , Ukraine
Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University
Donetsk, , Ukraine
State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology
Kharkiv, , Ukraine
State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology
Kharkiv, , Ukraine
State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych
Kharkiv, , Ukraine
State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department
Kiev, , Ukraine
Communal Institution "Lviv Regional Clinical Psych Hospital"
Lviv, , Ukraine
Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care
Odesa, , Ukraine
Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev
Poltava, , Ukraine
Crimean Republican Institution "Clinical Psychiatric Hospital #1"
Simferopol, , Ukraine
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, , Ukraine
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Final
Document Type: Study Protocol: Amendment history
Other Identifiers
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093-050
Identifier Type: -
Identifier Source: org_study_id
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