Eslicarbazepine Acetate Monotherapy Long Term Study

Epilepsy Clinical Trial

Official title:

Long Term Eslicarbazepine Acetate Extension Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910247
• Other study ID #: 093-050
• Status: Completed
• Phase: Phase 3
• Start date: August 2009
• Est. completion date: April 15, 2017

Study information

• Verified date: July 2018
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: April 15, 2017
• Est. primary completion date: April 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Eslicarbazepine acetate
800 to 2400 mg once daily (QD)

Locations

Country	Name	City	State
Bulgaria	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
Canada	Neuro-Epilepsy Clinic/ Neuro Rive-Sud	Greenfield Park	Quebec
Canada	London Health Sciences Centre, University Campus	London	Ontario
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Czechia	Poradna pro epilepsie	Koty	Zlin
Czechia	Evzen Nespor	Praha	Strasnice
Czechia	Neurologicka ordinance	Praha 6
Czechia	CTC Rychnov nad Kneznou	Rychnov nad Kneznou	Praugue
Czechia	Policlinic Chocen, Private Neurology	Smetanova Lhota	Chocen
Czechia	Cerebrovaskularni poradna s.r.o	Trebovice	Ostrava
Serbia	Clinic of Neurology, Clinical Center of Serbia	Belgrade
Serbia	Institute of Mental Health, Department of epilepsy and clinical neurophysiology	Belgrade
Ukraine	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 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	Kharkov
Ukraine	State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology	Kharkov
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	Odessa
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
United States	McFarland Clinic, PC	Ames	Iowa
United States	Neurology Associates of Arlington, P.A.	Arlington	Texas
United States	PANDA Neurology and Atlanta Heachache Specialists	Atlanta	Georgia
United States	JEM Research, LLC	Atlantis	Florida
United States	Neurosciences Clinic - University of Colorado Hospital	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	Neurological Associates of Washington	Bellevue	Washington
United States	Sutter East Bay Medical Foundation	Berkeley	California
United States	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland
United States	Consultants in Epilepsy and Nuerology	Boise	Idaho
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Bradenton Clinical Research	Bradenton	Florida
United States	Montefiore Medical Center	Bronx	New York
United States	Edwin A Green, Jr., MD	Brownwood	Texas
United States	Lahey Clinic	Burlington	Massachusetts
United States	Ohio Clinical Research Partners, LLC	Canton	Ohio
United States	Five Towns Neuroscience Research	Cedarhurst	New York
United States	Comprehensive Epilepsy Care Center for Children and Adults	Chesterfield	Missouri
United States	Arkansas Neurology	Conway	Arkansas
United States	Miami Research Inc.	Coral Gables	Florida
United States	Gus Stratton / Neurology	Cranston	Rhode Island
United States	Neurological Clinic of Texas, P.A.	Dallas	Texas
United States	Texas Neurology, PA	Dallas	Texas
United States	Associated Nuerologists, PC	Danbury	Connecticut
United States	Denver Health	Denver	Colorado
United States	Wayne State University/Detroit Medical Center	Detroit	Michigan
United States	Precise Research Centers	Flowood	Mississippi
United States	Neuro-Pain Medical Center	Fresno	California
United States	Collaborative Neuroscience Network	Garden Grove	California
United States	Minneappolis Clinic of Neurology	Golden Valley	Minnesota
United States	NW FL Clinical Research Group, LLC	Gulf Breeze	Florida
United States	Northeast Regional Epilepsy Group	Hackensack	New Jersey
United States	ECommunity Research LLC	Hammond	Louisiana
United States	Palm Springs Research Institute	Hialeah	Florida
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Infinity Clinical Research, LLC	Hollywood	Florida
United States	MD	Houston	Texas
United States	UT Health Science Center at Houston/ Dept of Neurology	Houston	Texas
United States	J.W.M. Neurology P.C.	Indianapolis	Indiana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Bluegrass Epilepsy Research, LLC	Lexington	Kentucky
United States	K&S Professional Research Services, LLC	Little Rock	Arkansas
United States	Faculty of Physicians and Surgeons of Loma Linda University	Loma Linda	California
United States	Neurology Associates	Maitland	Florida
United States	Neurology Associates of Arlington, P.A.	Mansfield	Texas
United States	Miami Children's Hospital	Miami	Florida
United States	Neuroscience Consultants	Miami	Florida
United States	San Marcus Research Clinic	Miami	Florida
United States	Regional Epilepsy Center	Milwaukee	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	Viking Clinical Research	Murrieta	California
United States	Viking Clinical Research Center	Murrieta	California
United States	VU Department of Neurology	Nashville	Tennessee
United States	Jersey Shore University Medical Center	Neptune	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	Neurology Clinic, P.C.	Northport	Alabama
United States	Northridge Neurological Research Center	Northridge	California
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Sooner Clinical Research	Oklahoma City	Oklahoma
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	Yafa Minazad	Pasadena	California
United States	OSF Saint Francis Medical Center	Peoria	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Temple University School of Medicine, Dept of Neurology	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	21st Century Neurology, a division of Xenoscience, Inc.	Phoenix	Arizona
United States	Clinical Research Consortium-Arizona	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Medsol Clinical Research Center	Port Charlotte	Florida
United States	Rainier Clinical Research Center Inc.	Renton	Washington
United States	University of Rochester	Rochester	New York
United States	Harbin Clinic	Rome	Georgia
United States	PsychCare Consultants Research	Saint Louis	Missouri
United States	University of Utah Department of Neurology	Salt Lake City	Utah
United States	Innovative Clinical Trials	San Antonio	Texas
United States	Road Runner Research	San Antonio	Texas
United States	Neurological Research Institute	Santa Monica	California
United States	MMP Neuroloy	Scarborough	Maine
United States	Pacific Medical Centers	Seattle	Washington
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	Arizona Neurological Institute	Sun City	Arizona
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Pediatric Epilepsy & Neurology Specialists, PA	Tampa	Florida
United States	Scott and White Memorial Hospital	Temple	Texas
United States	The University of Toledo Health Science Campus	Toledo	Ohio
United States	Collaborative Neuroscience Network	Torrance	California
United States	Center for Neurosciences	Tucson	Arizona
United States	University of Arizona, Health Sciences Center	Tucson	Arizona
United States	Tulsa Clinical Research LLC	Tulsa	Oklahoma
United States	Neurosearch II Inc	Ventura	California
United States	Palm Beach Clinical Research Network, LLC	Wellington	Florida
United States	Central DuPage Hospital	Winfield	Illinois
United States	Department of Neurology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Percent of Subjects With Treatment Emergent Adverse Events	Number and percent of subjects with treatment emergent adverse events	One year
Secondary	Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations	Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations	1 year
Secondary	Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium =135 mmol/L, =130 mmol/L, and =125 mmol/L	Number and percentage of subjects who had normal sodium value (i.e. >135 mEq/L) at baseline but reached <=135 mEq/L and >130 mEq/L, <=130 mEq/L and >125 mEq/L, or <=125 mEq/L at any post baseline.	1 year
Secondary	Percentage of Subjects With Increase of Body Weight =7%	Percentage of subjects with increase of body weight =7%	1 year
Secondary	Number and Percentage of Subjects With Orthostatic Effects.	Number and percentage of subjects with orthostatic effects.	1 year
Secondary	Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.	Number and percentage of subjects by QT interval corrected using the Fridericia fomula (QTcF) categories; Based on the numbers of subjects who had at least one post-baseline assessment, the number and percentage of subjects with QTcF values in the following categories were summarized: >500 millisecond (msec) at any post-baseline timepoint but not present at baseline; >480 msec at any post-baseline timepoint but not present at baseline; >450 msec at any post-baseline timepoint but not present at baseline; Change from Baseline >=60 ms for at least one post-baseline measurement; Change from Baseline >=30 ms for at least one post-baseline measurement and <60 ms for all post-baseline measurement; QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle.	Baseline, Month 12
Secondary	Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).	The C-SSRS is an instrument designed to systematically assess and track suicidal behavior and suicidal ideation. The C-SSRS will be completed by the Investigator or Sub-Investigator (or qualified site personnel).; Suicidal ideation is collected as any occurrence of wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act, without specific plan, active suicidal ideation with specific plan and intent.; Suicidal behavior is collected as any occurrence of actual attempts, Non-Suicidal Self-Injurious Behavior, interrupted attempts, aborted attempts, or preparatory acts or behavior, suicidal behavior.; Any suicidality is defined as having at least one occurrence of Suicidal Behavior or Suicidal Ideation.	1 year
Secondary	Time on Eslicarbazepine Acetate Monotherapy.	The start of the monotherapy period was defined as the date of termination of all other anti-epileptic drugs while taking study medication. Time on eslicarbazepine acetate monotherapy is defined from the date of the first monotherapy dose in 093-045 or 093-046 study to the last known dose of monotherapy treatment, regardless of dose change and the time gap between the parent studies and the current study.	One year
Secondary	Change in Seizure Frequency From Baseline.	Relative (%) change in standard seizure frequency(SSF) from baseline	Month 12 from baseline
Secondary	Responder Rate (Percentage of Subjects With a =50% Reduction of Seizure Frequency From Baseline).	Responder rate (percentage of subjects with a =50% reduction of seizure frequency from baseline).	One year
Secondary	Percentage of Subjects That Are Seizure-free During Study	Percentage of subjects that are seizure-free during study	1 year
Secondary	Completion Rate (% of Subjects Completing the One Year Treatment)	Completion rate (% of subjects completing the one year treatment)	One year
Secondary	Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)	The retention time is defined from the start of eslicarbazepine acetate monotherapy period in 093-045 or 093-046 to the last known dose of open-label eslicarbazepine acetate. The time may include taking eslicarbazepine acetate concomitantly with other anti-epileptic drugs. If a subject's termination reason(s) includes: withdrawal of consent, lost to follow-up, physician decision or other, then it was assumed the subject terminated the study due to lack of efficacy.	One year
Secondary	Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).	Change in the overall score from baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31 ); The QOLIE-31 overall score was obtained by using a weighted average of multi-item scale scores. The recorded responses were converted to 0-100 point scales. The mean of the individual item scores in each subgroup were calculated, with higher converted scores reflecting better quality of life.	baseline and Month 12
Secondary	Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).	The total score of MADRS is defined as the sum of all individual item scores. Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.	1 year
Secondary	Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of =14 at Screening	The total score of MADRS is defined as the sum of all individual item scores . Each of the 10 symptoms of depression on MADRS is measured on a scale of 0 to 6 with 0 representing the lowest severity of the symptom and 6 representing the highest severity.	baseline and Month 12
Secondary	Completion Rate (% of Subjects Completing Each Visit Post-one Year).	Completion rate (% of subjects completing each visit post-one year).	post 1 year