Clinical trial NCT00910247: Eslicarbazepine Acetate Monotherapy Long Term Study
Official title: Long Term Eslicarbazepine Acetate Extension Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Seizures
Epilepsy
Anticonvulsant
Monotherapy
Epilepsy with simple or complete partial onset seizures
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-29
Enrollment: 274
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number and Percent of Subjects With Treatment Emergent Adverse Events
timeFrame: One year
Secondary outcomes:
measure: Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations
timeFrame: 1 year
measure: Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
timeFrame: 1 year
measure: Percentage of Subjects With Increase of Body Weight ≥7%
timeFrame: 1 year
measure: Number and Percentage of Subjects With Orthostatic Effects.
timeFrame: 1 year
measure: Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.
timeFrame: Baseline, Month 12
measure: Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).
timeFrame: 1 year
measure: Time on Eslicarbazepine Acetate Monotherapy.
timeFrame: One year
measure: Change in Seizure Frequency From Baseline.
timeFrame: Month 12 from baseline
measure: Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).
timeFrame: One year
measure: Percentage of Subjects That Are Seizure-free During Study
timeFrame: 1 year
measure: Completion Rate (% of Subjects Completing the One Year Treatment)
timeFrame: One year
measure: Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)
timeFrame: One year
measure: Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).
timeFrame: baseline and Month 12
measure: Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).
timeFrame: 1 year
measure: Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening
timeFrame: baseline and Month 12
measure: Completion Rate (% of Subjects Completing Each Visit Post-one Year).
timeFrame: post 1 year
Other outcomes:
Locations:
city: Northport
country: United States
facility: Neurology Clinic, P.C.
state: Alabama
city: Phoenix
country: United States
facility: 21st Century Neurology, a division of Xenoscience, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Consortium-Arizona
state: Arizona
city: Sun City
country: United States
facility: Arizona Neurological Institute
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Tucson
country: United States
facility: University of Arizona, Health Sciences Center
state: Arizona
city: Conway
country: United States
facility: Arkansas Neurology
state: Arkansas
city: Little Rock
country: United States
facility: K&S Professional Research Services, LLC
state: Arkansas
city: Berkeley
country: United States
facility: Sutter East Bay Medical Foundation
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Loma Linda
country: United States
facility: Faculty of Physicians and Surgeons of Loma Linda University
state: California
city: Murrieta
country: United States
facility: Viking Clinical Research Center
state: California
city: Murrieta
country: United States
facility: Viking Clinical Research
state: California
city: Northridge
country: United States
facility: Northridge Neurological Research Center
state: California
city: Pasadena
country: United States
facility: Yafa Minazad
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Ventura
country: United States
facility: Neurosearch II Inc
state: California
city: Aurora
country: United States
facility: Neurosciences Clinic - University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: Denver Health
state: Colorado
city: Danbury
country: United States
facility: Associated Nuerologists, PC
state: Connecticut
city: Atlantis
country: United States
facility: JEM Research, LLC
state: Florida
city: Bradenton
country: United States
facility: Bradenton Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Miami Research Inc.
state: Florida
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group, LLC
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Maitland
country: United States
facility: Neurology Associates
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Miami
country: United States
facility: Neuroscience Consultants
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurology, PA
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Panama City
country: United States
facility: Bay Neurological Institute
state: Florida
city: Port Charlotte
country: United States
facility: Medsol Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Pediatric Epilepsy & Neurology Specialists, PA
state: Florida
city: Wellington
country: United States
facility: Palm Beach Clinical Research Network, LLC
state: Florida
city: Atlanta
country: United States
facility: PANDA Neurology and Atlanta Heachache Specialists
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Boise
country: United States
facility: Consultants in Epilepsy and Nuerology
state: Idaho
city: Peoria
country: United States
facility: OSF Saint Francis Medical Center
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Indianapolis
country: United States
facility: J.W.M. Neurology P.C.
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, PC
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Bluegrass Epilepsy Research, LLC
state: Kentucky
city: Hammond
country: United States
facility: ECommunity Research LLC
state: Louisiana
city: Scarborough
country: United States
facility: MMP Neuroloy
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University/Detroit Medical Center
state: Michigan
city: Golden Valley
country: United States
facility: Minneappolis Clinic of Neurology
state: Minnesota
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Chesterfield
country: United States
facility: Comprehensive Epilepsy Care Center for Children and Adults
state: Missouri
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Hackensack
country: United States
facility: Northeast Regional Epilepsy Group
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: University Medicine and Dentistry of New Jersey
state: New Jersey
city: Newark
country: United States
facility: UMDNJ DOC 8th Floor 8100
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Cedarhurst
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: Department of Neurology
state: North Carolina
city: Canton
country: United States
facility: Ohio Clinical Research Partners, LLC
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo Health Science Campus
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Sooner Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research LLC
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Medicine, Dept of Neurology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Cranston
country: United States
facility: Gus Stratton / Neurology
state: Rhode Island
city: Nashville
country: United States
facility: VU Department of Neurology
state: Tennessee
city: Arlington
country: United States
facility: Neurology Associates of Arlington, P.A.
state: Texas
city: Brownwood
country: United States
facility: Edwin A Green, Jr., MD
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Dallas
country: United States
facility: Neurological Clinic of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: UT Health Science Center at Houston/ Dept of Neurology
state: Texas
city: Houston
country: United States
facility: MD
state: Texas
city: Mansfield
country: United States
facility: Neurology Associates of Arlington, P.A.
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Department of Neurology
state: Utah
city: Bellevue
country: United States
facility: Neurological Associates of Washington
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center Inc.
state: Washington
city: Seattle
country: United States
facility: Pacific Medical Centers
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Regional Epilepsy Center
state: Wisconsin
city: Blagoevgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad
city: Pleven
country: Bulgaria
facility: Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven
city: Sofia
country: Bulgaria
facility: Second Multiprofile Hospital for Active Treatment
city: Varna
country: Bulgaria
facility: Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office
city: London
country: Canada
facility: London Health Sciences Centre, University Campus
state: Ontario
city: Greenfield Park
country: Canada
facility: Neuro-Epilepsy Clinic/ Neuro Rive-Sud
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Smetanova Lhota
country: Czechia
facility: Policlinic Chocen, Private Neurology
state: Chocen
city: Třebovice
country: Czechia
facility: Cerebrovaskularni poradna s.r.o
state: Ostrava
city: Rychnov nad Kneznou
country: Czechia
facility: CTC Rychnov nad Kneznou
state: Praugue
city: Praha
country: Czechia
facility: Evzen Nespor
state: Strasnice
city: Koty
country: Czechia
facility: Poradna pro epilepsie
state: Zlin
city: Praha 6
country: Czechia
facility: Neurologicka ordinance
city: Belgrade
country: Serbia
facility: Clinic of Neurology, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Institute of Mental Health, Department of epilepsy and clinical neurophysiology
city: Dnipropetrovsk
country: Ukraine
facility: 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: Donetsk
country: Ukraine
facility: Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University
city: Kharkiv
country: Ukraine
facility: State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology
city: Kharkov
country: Ukraine
facility: State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology
city: Kharkov
country: Ukraine
facility: State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych
city: Kiev
country: Ukraine
facility: State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department
city: Lviv
country: Ukraine
facility: Communal Institution "Lviv Regional Clinical Psych Hospital"
city: Odessa
country: Ukraine
facility: Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care
city: Poltava
country: Ukraine
facility: Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev
city: Simferopol
country: Ukraine
facility: Crimean Republican Institution "Clinical Psychiatric Hospital #1"
city: Vinnytsia
country: Ukraine
facility: 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
Study officials:
affiliation: Sunovion Pharmaceuticals
name: CNS Medical Director
role: STUDY_DIRECTOR
References: