Eslicarbazepine Acetate Monotherapy Long Term Study



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - 70
Updated:7/19/2018
Start Date:August 2009
End Date:April 15, 2017

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Long Term Eslicarbazepine Acetate Extension Study

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

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.

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.
We found this trial at
97
sites
Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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7485 Sandlake Commons Blvd.
Orlando, Florida 32835
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8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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5430 Fredericksburg Road
San Antonio, Texas 78229
210-377-2873
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2450 E. River Road
Tucson, Arizona 85718
520-320-2147
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Arlington, Texas 76017
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Atlantis, Florida 33462
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Bellevue, Washington 98004
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Berkeley, California 94705
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Bethesda, Maryland 20817
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Bradenton, Florida 34205
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2400 Crockett Drive
Brownwood, Texas 76801
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Cedarhurst, New York
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Conway, Arkansas 72034
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Coral Gables, Florida 33134
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Cranston, Rhode Island 02920
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Dallas, Texas 75230
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Dallas, Texas 75214
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Danbury, Connecticut 06810
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Denver, Colorado 80204
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4201 St Antoine St
Detroit, Michigan 48201
(313) 577-1429
Wayne State University/Detroit Medical Center Founded in 1868, the Wayne State University School of Medicine...
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Flowood, Mississippi 39232
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Garden Grove, California 92845
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Golden Valley, Minnesota 55422
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Gulf Breeze, Florida 32561
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Hackensack, New Jersey 07601
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Hammond, Louisiana 70403
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Hialeah, Florida 33012
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Hickory, North Carolina 28602
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Hollywood, Florida 33021
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Indianapolis, Indiana 46237
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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Lexington, Kentucky 40504
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Little Rock, Arkansas 72201
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Maitland, Florida 32751
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Mansfield, Texas 76063
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Miami, Florida 33176
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Miami, Florida 33015
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Milwaukee, Wisconsin 53215
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Murrieta, California 92562
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24910 Las Brisas Road
Murrieta, California 92562
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Nashville, Tennessee 37232
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Neptune, New Jersey 07754
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New Brunswick, New Jersey 08901
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Newark, New Jersey 07103
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Northport, Alabama 35476
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Northridge, California 91325
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3555 NW 58th St # 800
Oklahoma City, Oklahoma 73112
(405) 447-8839
Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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Oklahoma City, Oklahoma 73112
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Panama City, Florida 32405
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Pasadena, California 91105
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Peoria, Illinois 61637
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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3500 North Broad Street
Philadelphia, Pennsylvania 19140
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Port Charlotte, Florida 33952
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Renton, Washington 98057
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Rome, Georgia 30165
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5000 Cedar Plaza Parkway
Saint Louis, Missouri 63128
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Salt Lake City, Utah 84132
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San Antonio, Texas 78258
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Santa Monica, California 90404
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Scarborough, Maine 04704
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Seattle, Washington 98144
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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Sun City, Arizona 85351
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750 East Adams Street
Syracuse, New York 13210
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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Torrance, California 90502
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1295 North Martin Avenue
Tucson, Arizona 85721
(520) 626-1197
University of Arizona Health Sciences Center The Arizona Health Sciences Center (AHSC) at the University...
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Tulsa, Oklahoma 74104
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Ventura, California 93003
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Wellington, Florida 33414
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Winfield, Illinois 60190
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Winston-Salem, North Carolina 27517
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