Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:16 - 70
Updated:4/21/2016
Start Date:April 2009
End Date:May 2013

Use our guide to learn which trials are right for you!

Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs

This is an 18-week, double-blind, multicenter study with gradual conversion from previous
antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial
epilepsy.

This is an 18-week, double-blind, randomized, historical control, multicenter study with
gradual conversion to monotherapy in subjects with partial onset seizures who are not well
controlled by current AEDs. The 18 week double-blind treatment period consists of a 2-week
period for titration of study drug, 6-week period for taper or conversion off AEDs, and a
10-week monotherapy period. Subjects not entering an optional open-label extension study
will enter a 1-week period to taper off study drug followed by an end of study visit (week
19). 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.

Inclusion Criteria:

- Diagnosis of partial epilepsy as defined in the Classification of Seizures of the
International League Against Epilepsy (ILAE) (simple partial seizures with observable
motor component, or complex, with or without secondary generalization) a. Medical
history of seizures; b. Absence of confounding factors (pseudoseizures, syncope); c.
Documented EEG recording (done within 5 years prior to screening) consistent with
focal onset epilepsy.

- Documented CT or MRI scan conducted within 10 years prior to screening, showing the
absence of a progressive structural abnormality (eg, tumor). Mesial temporal
sclerosis is acceptable.

- ≥4 partial onset seizures during the 8 weeks prior screening with no 28-day seizure
free period.

- Stable treatment with 1-2 AEDs during the last 4 weeks prior to screening.

- Subjects must have the ability to comprehend the informed consent form and be willing
to provide informed consent. For subjects who are unable to comprehend the written
consent, a witness/caregiver who is able to describe and provide an understanding of
the informed consent to the subject must sign the consent form on behalf of the
subject.

- Subjects 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. Subjects of Asian ancestry are required to give written informed consent for
genotyping. All subjects must sign a HIPAA Form. All females of child bearing
potential must also sign the "Women of Childbearing Potential" Addendum.

- A female subject is eligible to enter and participate in the study if she is of: a.
Non-childbearing potential (ie, physiologically incapable of becoming pregnant,
including any female who is pre-menarchal or post-menopausal); b. Child-bearing
potential (all females ≤65 years of age), has a negative pregnancy test at screening
and agrees to satisfy contraception requirements.

Exclusion Criteria:

- Subjects with only simple partial seizures without a motor component.

- Presence of generalized seizure syndromes (eg, juvenile myoclonic epilepsy or
Lennox-Gastaut syndrome).

- History of pseudo-seizures.

- Current seizures related to an acute medical illness.

- Seizures secondary to metabolic, toxic or infectious disorder or drug abuse.

- Status epilepticus within 2 years prior to screening.

- Seizures only occurring in a cluster pattern.

- Subjects taking 2 of the following sodium channel blocking AEDs: phenytoin,
carbamazepine, oxcarbazepine, or lamotrigine.

- Subjects taking 2 AEDs with both being in the upper dose range (defined as
approximately two-thirds of the defined daily dose).

- Subjects taking more than 2 AEDs.

- Subjects with progressive structural central nervous system lesion or progressive
encephalopathy.

- Psychiatric exclusion criteria: subjects with history of suicide attempt in last 2
years; major depressive episode within last 6 months; abuse of alcohol or substance
abuse in last 2 years; significant psychiatric disorder or recurrent episodes of
severe depression within 2 years prior to screening.

- Medical exclusion criteria: known renal insufficiency or subject with estimated
creatinine clearance [CrCL] <60 mL/min based on serum creatinine using the
Cockcroft-Gault formula.

- Clinical and laboratory exclusion criteria: Subjects of Asian ancestry who tests
positive for the presence of the HLA-B*1502 allele.

- Subjects who have been on benzodiazepines, phenobarbital, or primidone on a regular
basis within 3 months prior to screening.

- Subjects taking antipsychotics, tricyclic antidepressants, anxiolytics, sedative
hypnotics including non-benzodiazepines, central opioid agonists/antagonists,
monoamine oxidase inhibitors (MAOIs) within at least 5 half lives (or for at least 2
weeks whichever is longer) prior to randomization.

- Subjects presently on felbamate or vigabatrin

- Female subjects who are currently breastfeeding or intending to breastfeed during
study period.
We found this trial at
104
sites
777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
?
mi
from
Denver, CO
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3924 9th Avenue West
Bradenton, Florida 34205
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
305 1st Avenue # Dazian 7
New York, New York 10003
(212) 420-2806
Beth Israel Med Ctr The physicians and staff of Mount Sinai Beth Israel's Heart Institute...
?
mi
from
New York, NY
Click here to add this to my saved trials
8 Mirror Lake Dr # A
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
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....
?
mi
from
Rochester, NY
Click here to add this to my saved trials
2450 E. River Road
Tucson, Arizona 85718
520-320-2147
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
?
mi
from
Ames, IA
Click here to add this to my saved trials
Arlington, Texas 76017
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30309
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1101 East 33rd Street
Baltimore, Maryland 21287
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellevue, Ohio 44811
?
mi
from
Bellevue, OH
Click here to add this to my saved trials
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Berkley, California 94705
?
mi
from
Berkley, CA
Click here to add this to my saved trials
Bethesda, Maryland 20817
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Birmingham, Alabama 35242
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
Birmingham, Alabama 35234
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
Camden, New Jersey 08103
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Cedarhurst, New York
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cherry Hill, New Jersey 08034
?
mi
from
Cherry Hill, NJ
Click here to add this to my saved trials
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Coral Gables, Florida 33134
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Cranston, Rhode Island 02920
?
mi
from
Cranston, RI
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dallas, Texas 75214
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Edison, New Jersey 08818
?
mi
from
Edison, NJ
Click here to add this to my saved trials
Escondido, California 92025
?
mi
from
Escondido, CA
Click here to add this to my saved trials
Flowood, Mississippi 39232
?
mi
from
Flowood, MS
Click here to add this to my saved trials
Garden Grove, California 92845
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
Germantown, Tennessee 38138
?
mi
from
Germantown, TN
Click here to add this to my saved trials
Gulf Breeze, Florida 32561
?
mi
from
Gulf Breeze, FL
Click here to add this to my saved trials
Hammond, Louisiana 70403
?
mi
from
Hammond, LA
Click here to add this to my saved trials
Hickory, North Carolina 28602
?
mi
from
Hickory, NC
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Houston, Texas 77063
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32209
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
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...
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Lexington, Kentucky 40504
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Little Rock, Arkansas 72201
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
?
mi
from
London,
Click here to add this to my saved trials
Los Gatos, California 95032
?
mi
from
Los Gatos, CA
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
Mansfield, Texas 76063
?
mi
from
Mansfield, TX
Click here to add this to my saved trials
Medford, Oregon 97504
?
mi
from
Medford, OR
Click here to add this to my saved trials
Melbourne, Florida 32901
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
Miami, Florida 33176
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33015
?
mi
from
Miami, FL
Click here to add this to my saved trials
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
?
mi
from
Mineola, NY
Click here to add this to my saved trials
Mobile, Alabama 36693
?
mi
from
Mobile, AL
Click here to add this to my saved trials
Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Neptune, New Jersey 07754
?
mi
from
Neptune, NJ
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
New York, New York 10019
?
mi
from
New York, NY
Click here to add this to my saved trials
Norfolk, Virginia 23507
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Northport, Alabama 35476
?
mi
from
Northport, AL
Click here to add this to my saved trials
Northridge, California 91325
?
mi
from
Northridge, CA
Click here to add this to my saved trials
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...
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32819
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Pasadena, California 91105
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Paterson, New Jersey 07503
?
mi
from
Paterson, NJ
Click here to add this to my saved trials
Peoria, Illinois 61637
?
mi
from
Peoria, IL
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85004
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85004
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburg, Pennsylvania 15201
?
mi
from
Pittsburg, PA
Click here to add this to my saved trials
Port Charlotte, Florida 33952
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Renton, Washington 98057
?
mi
from
Renton, WA
Click here to add this to my saved trials
Rome, Georgia 30165
?
mi
from
Rome, GA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Scarborough, Maine 04074
?
mi
from
Scarborough, ME
Click here to add this to my saved trials
Seattle, Washington 98144
?
mi
from
Seattle, WA
Click here to add this to my saved trials
327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
?
mi
from
Springfield, IL
Click here to add this to my saved trials
St. Louis, Missouri 63128
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
Sun City, Arizona 85351
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
?
mi
from
Suwanee, GA
Click here to add this to my saved trials
Tallahassee, Florida 32308
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
?
mi
from
Temple, TX
Click here to add this to my saved trials
Vero Beach, Florida 32960
?
mi
from
Vero Beach, FL
Click here to add this to my saved trials
Wellington, Florida 33414
?
mi
from
Wellington, FL
Click here to add this to my saved trials