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 |
Long Term Eslicarbazepine Acetate Extension Study
This is a long term, open-label, safety extension study in subjects with partial onset
seizures.
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.
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
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Miami Children's Hospital Welcome to Miami Children
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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
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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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
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Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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4201 St Antoine St
Detroit, Michigan 48201
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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University of Kansas Medical Center The University of Kansas Medical Center serves Kansas through excellence...
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West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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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
Philadelphia, Pennsylvania 19140
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801 N Rutledge St
Springfield, Illinois 62702
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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Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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1295 North Martin Avenue
Tucson, Arizona 85721
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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