Eslicarbazepine Acetate Monotherapy Long Term Study

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00910247
• Collaborator: (none)
• Enrollment: 274
• Locations: 122
• Arm: 1
• Duration (Months): 92.5
• Patients Per Site: 2.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Eslicarbazepine acetate	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 274 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: open label
• Primary Purpose: Treatment
• Official Title: Long Term Eslicarbazepine Acetate Extension Study
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Apr 15, 2017
• Actual Study Completion Date: Apr 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: eslicarbazepine acetate Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD	Drug: Eslicarbazepine acetate; 800 to 2400 mg once daily (QD); Other Names: SEP-0002093 BIA 2-093

Outcome Measures

Primary Outcome Measures

1. Number and Percent of Subjects With Treatment Emergent Adverse Events [One year]

   Number and percent of subjects with treatment emergent adverse events

Secondary Outcome Measures

1. Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations [1 year]

   Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations

2. Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L [1 year]

   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.

3. Percentage of Subjects With Increase of Body Weight ≥7% [1 year]

   Percentage of subjects with increase of body weight ≥7%

4. Number and Percentage of Subjects With Orthostatic Effects. [1 year]

   Number and percentage of subjects with orthostatic effects.

5. Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. [Baseline, Month 12]

   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.

6. Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS). [1 year]

   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.

7. Time on Eslicarbazepine Acetate Monotherapy. [One year]

   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.

8. Change in Seizure Frequency From Baseline. [Month 12 from baseline]

   Relative (%) change in standard seizure frequency(SSF) from baseline

9. Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline). [One year]

   Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).

10. Percentage of Subjects That Are Seizure-free During Study [1 year]

    Percentage of subjects that are seizure-free during study

11. Completion Rate (% of Subjects Completing the One Year Treatment) [One year]

    Completion rate (% of subjects completing the one year treatment)

12. Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events) [One year]

    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.

13. Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31). [baseline and Month 12]

    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.

14. Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS). [1 year]

    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.

15. Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening [baseline and Month 12]

    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.

16. Completion Rate (% of Subjects Completing Each Visit Post-one Year). [post 1 year]

    Completion rate (% of subjects completing each visit post-one year).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurology Clinic, P.C.	Northport	Alabama	United States	35476
2	21st Century Neurology, a division of Xenoscience, Inc.	Phoenix	Arizona	United States	85004
3	Clinical Research Consortium-Arizona	Phoenix	Arizona	United States	85004
4	Arizona Neurological Institute	Sun City	Arizona	United States	85351
5	Center for Neurosciences	Tucson	Arizona	United States	85718
6	University of Arizona, Health Sciences Center	Tucson	Arizona	United States	85724
7	Arkansas Neurology	Conway	Arkansas	United States	72034
8	K&S Professional Research Services, LLC	Little Rock	Arkansas	United States	72201
9	Sutter East Bay Medical Foundation	Berkeley	California	United States	94705
10	Neuro-Pain Medical Center	Fresno	California	United States	93710
11	Collaborative Neuroscience Network	Garden Grove	California	United States	92845
12	Faculty of Physicians and Surgeons of Loma Linda University	Loma Linda	California	United States	92354
13	Viking Clinical Research Center	Murrieta	California	United States	92562
14	Viking Clinical Research	Murrieta	California	United States	92562
15	Northridge Neurological Research Center	Northridge	California	United States	91325
16	Yafa Minazad	Pasadena	California	United States	91105
17	Neurological Research Institute	Santa Monica	California	United States	90404
18	Collaborative Neuroscience Network	Torrance	California	United States	90502
19	Neurosearch II Inc	Ventura	California	United States	93003
20	Neurosciences Clinic - University of Colorado Hospital	Aurora	Colorado	United States	80045
21	Denver Health	Denver	Colorado	United States	80204
22	Associated Nuerologists, PC	Danbury	Connecticut	United States	06810
23	JEM Research, LLC	Atlantis	Florida	United States	33462
24	Bradenton Clinical Research	Bradenton	Florida	United States	34205
25	Miami Research Inc.	Coral Gables	Florida	United States	33134
26	NW FL Clinical Research Group, LLC	Gulf Breeze	Florida	United States	32561
27	Palm Springs Research Institute	Hialeah	Florida	United States	33012
28	Infinity Clinical Research, LLC	Hollywood	Florida	United States	33021
29	Neurology Associates	Maitland	Florida	United States	32751
30	San Marcus Research Clinic	Miami	Florida	United States	33015
31	Miami Children's Hospital	Miami	Florida	United States	33155
32	Neuroscience Consultants	Miami	Florida	United States	33176
33	Pediatric Neurology, PA	Orlando	Florida	United States	32819
34	Neurology Associates of Ormond Beach	Ormond Beach	Florida	United States	32174
35	Bay Neurological Institute	Panama City	Florida	United States	32405
36	Medsol Clinical Research Center	Port Charlotte	Florida	United States	33952
37	Pediatric Epilepsy & Neurology Specialists, PA	Tampa	Florida	United States	33609
38	Palm Beach Clinical Research Network, LLC	Wellington	Florida	United States	33414
39	PANDA Neurology and Atlanta Heachache Specialists	Atlanta	Georgia	United States	30328
40	Harbin Clinic	Rome	Georgia	United States	30165
41	Consultants in Epilepsy and Nuerology	Boise	Idaho	United States	83702
42	OSF Saint Francis Medical Center	Peoria	Illinois	United States	61637
43	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
44	Central DuPage Hospital	Winfield	Illinois	United States	60190
45	J.W.M. Neurology P.C.	Indianapolis	Indiana	United States	46237
46	McFarland Clinic, PC	Ames	Iowa	United States	50010
47	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
48	Bluegrass Epilepsy Research, LLC	Lexington	Kentucky	United States	40504
49	ECommunity Research LLC	Hammond	Louisiana	United States	70403
50	MMP Neuroloy	Scarborough	Maine	United States	04704
51	Johns Hopkins University	Baltimore	Maryland	United States	21287
52	Mid-Atlantic Epilepsy and Sleep Center	Bethesda	Maryland	United States	20817
53	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
54	Lahey Clinic	Burlington	Massachusetts	United States	01805
55	Wayne State University/Detroit Medical Center	Detroit	Michigan	United States	48201
56	Minneappolis Clinic of Neurology	Golden Valley	Minnesota	United States	55422
57	Precise Research Centers	Flowood	Mississippi	United States	39232
58	Comprehensive Epilepsy Care Center for Children and Adults	Chesterfield	Missouri	United States	63017
59	PsychCare Consultants Research	Saint Louis	Missouri	United States	63128
60	Northeast Regional Epilepsy Group	Hackensack	New Jersey	United States	07601
61	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
62	University Medicine and Dentistry of New Jersey	New Brunswick	New Jersey	United States	08901
63	UMDNJ DOC 8th Floor 8100	Newark	New Jersey	United States	07103
64	Montefiore Medical Center	Bronx	New York	United States	10467
65	Five Towns Neuroscience Research	Cedarhurst	New York	United States	11516
66	University of Rochester	Rochester	New York	United States	14642
67	SUNY Upstate Medical University	Syracuse	New York	United States	13210
68	PMG Research of Hickory, LLC	Hickory	North Carolina	United States	28602
69	Department of Neurology	Winston-Salem	North Carolina	United States	27517
70	Ohio Clinical Research Partners, LLC	Canton	Ohio	United States	44718
71	The University of Toledo Health Science Campus	Toledo	Ohio	United States	43614
72	Lynn Health Science Institute	Oklahoma City	Oklahoma	United States	73112
73	Sooner Clinical Research	Oklahoma City	Oklahoma	United States	73112
74	Tulsa Clinical Research LLC	Tulsa	Oklahoma	United States	74104
75	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
76	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
77	Temple University School of Medicine, Dept of Neurology	Philadelphia	Pennsylvania	United States	19140
78	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15201
79	Gus Stratton / Neurology	Cranston	Rhode Island	United States	02920
80	VU Department of Neurology	Nashville	Tennessee	United States	37232
81	Neurology Associates of Arlington, P.A.	Arlington	Texas	United States	76107
82	Edwin A Green, Jr., MD	Brownwood	Texas	United States	76801
83	Texas Neurology, PA	Dallas	Texas	United States	75214
84	Neurological Clinic of Texas, P.A.	Dallas	Texas	United States	75230
85	UT Health Science Center at Houston/ Dept of Neurology	Houston	Texas	United States	77030
86	MD	Houston	Texas	United States	77063
87	Neurology Associates of Arlington, P.A.	Mansfield	Texas	United States	76063
88	Innovative Clinical Trials	San Antonio	Texas	United States	78229
89	Road Runner Research	San Antonio	Texas	United States	78258
90	Scott and White Memorial Hospital	Temple	Texas	United States	76508
91	University of Utah Department of Neurology	Salt Lake City	Utah	United States	84132
92	Neurological Associates of Washington	Bellevue	Washington	United States	98004
93	Rainier Clinical Research Center Inc.	Renton	Washington	United States	98057
94	Pacific Medical Centers	Seattle	Washington	United States	98144
95	West Virginia University	Morgantown	West Virginia	United States	26506
96	Regional Epilepsy Center	Milwaukee	Wisconsin	United States	53215
97	Multiprofile Hospital for Active Treatment "Pulse," AD, Town of Blagoegrad	Blagoevgrad		Bulgaria	2700
98	Univesity Multiprofile Hospital for Active Treatment "Dr. George Stranski," EAD, town of Pleven	Pleven		Bulgaria	5800
99	Second Multiprofile Hospital for Active Treatment	Sofia		Bulgaria	1202
100	Diagnostic and Consultative Center "Equita" EOOD, town of Varna Neurology office	Varna		Bulgaria	9000
101	London Health Sciences Centre, University Campus	London	Ontario	Canada	N6A 5A5
102	Neuro-Epilepsy Clinic/ Neuro Rive-Sud	Greenfield Park	Quebec	Canada	J4V 2J2
103	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4
104	Policlinic Chocen, Private Neurology	Smetanova Lhota	Chocen	Czechia	56501
105	Cerebrovaskularni poradna s.r.o	Třebovice	Ostrava	Czechia	722 00
106	CTC Rychnov nad Kneznou	Rychnov nad Kneznou	Praugue	Czechia	516 01
107	Evzen Nespor	Praha	Strasnice	Czechia
108	Poradna pro epilepsie	Koty	Zlin	Czechia	760 01
109	Neurologicka ordinance	Praha 6		Czechia	160 00
110	Clinic of Neurology, Clinical Center of Serbia	Belgrade		Serbia	11 000
111	Institute of Mental Health, Department of epilepsy and clinical neurophysiology	Belgrade		Serbia	11 000
112	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	49005
113	Communal Medical and Preventive Treatment Institution "Regional Clinical Psychiatric Hospital" Donetsk National Medical University	Donetsk		Ukraine	83008
114	State Institution "Institute of neurology, psychiatry, and narcology of AMS of Ukraine" Department of cerebrovascular patology	Kharkiv		Ukraine	61068
115	State Treatment and Prevention Institution " Central clinical hospital of Ukrzalizntysya" Neurology Department of Neuropathology and Child Neurology	Kharkov		Ukraine	61018
116	State Institution "Institute of the Health Care of Children and Adolescents of Academy of Medical Sciences of Ukraine Dept of Psych	Kharkov		Ukraine	61153
117	State Institution Railway Clinical Hospital #1 of Kiev Railway Station of DTGO South Western Railroad Psycho-neurological Department	Kiev		Ukraine	01030
118	Communal Institution "Lviv Regional Clinical Psych Hospital"	Lviv		Ukraine	79021
119	Communal Institution "Odessa Regional Clinical Psych Hospital #1" Department of Day Care	Odessa		Ukraine	65006
120	Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev	Poltava		Ukraine	36006
121	Crimean Republican Institution "Clinical Psychiatric Hospital #1"	Simferopol		Ukraine	95006
122	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		Ukraine	21005

Sponsors and Collaborators

• Sunovion

Investigators

• Study Director: CNS Medical Director, Sunovion Pharmaceuticals

Study Documents (Full-Text)

• Statistical Analysis Plan - May 19, 2017
• Study Protocol: Final - Jun 7, 2013
• Study Protocol: Amendment history - Nov 15, 2013

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT00910247
• Other Study ID Numbers: 093-050
• First Posted: May 29, 2009
• Last Update Posted: Jul 17, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by Sunovion: Seizures; Epilepsy; Anticonvulsant; Monotherapy; Epilepsy with simple or complete partial onset seizures
• Additional relevant MeSH terms: Epilepsy; Eslicarbazepine acetate

Study Results

Participant Flow

Recruitment Details	Subjects that participated in either study 093-045NCT00866775) or study 093-046(NCT01091662) were eligible to participate in study 093-050
Pre-assignment Detail	Subjects who completed the 18-week treatment period or exited the study per protocol may be eligible to participate. Subjects who discontinued for reasons other than reaching the exit criteria may be eligible if there is no safety concern, however, subjects must have completed at least the first 3 weeks of the 18-week double-blind treatment

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Period Title: Overall Study
STARTED	274
COMPLETED	205
NOT COMPLETED	69

Baseline Characteristics

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Overall Participants	274
Age (Count of Participants)
<=18 years	12 4.4%
Between 18 and 65 years	258 94.2%
>=65 years	4 1.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.9 (12.70)
Sex: Female, Male (Count of Participants)
Female	134 48.9%
Male	140 51.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 10.2%
Not Hispanic or Latino	246 89.8%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.7%
Asian	5 1.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	22 8%
White	229 83.6%
More than one race	2 0.7%
Unknown or Not Reported	14 5.1%
Region of Enrollment (participants) [Number]
Canada	3 1.1%
United States	167 60.9%
Czechia	27 9.9%
Ukraine	57 20.8%
Bulgaria	18 6.6%
Serbia	2 0.7%

Outcome Measures

1. Primary Outcome

Title	Number and Percent of Subjects With Treatment Emergent Adverse Events
Description	Number and percent of subjects with treatment emergent adverse events
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The Intent-to -Treat (ITT) population consisted of all subjects who had taken any open-label study medication

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Count of Participants [Participants]	220 80.3%

2. Secondary Outcome

Title	Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations
Description	Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Count of Participants [Participants]	186 67.9%

3. Secondary Outcome

Title	Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

ITT subjects with baseline sodium and at least one post baseline sodium value

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	261
<=135 mEq/L and >130 mEq/L	48 17.5%
<=130 mEq/L and >125 mEq/L	22 8%
<=125 mEq/L	4 1.5%

4. Secondary Outcome

Title	Percentage of Subjects With Increase of Body Weight ≥7%
Description	Percentage of subjects with increase of body weight ≥7%
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Number [percentagae of participants]	27 9.9%

5. Secondary Outcome

Title	Number and Percentage of Subjects With Orthostatic Effects.
Description	Number and percentage of subjects with orthostatic effects.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Count of Participants [Participants]	67 24.5%

6. Secondary Outcome

Title	Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.
Description	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.
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) subjects with at least one post-baseline assessment

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	272
>500ms at any postbaseline not present at baseli	0 0%
>450ms at any postbaseline not present at baseline	9 3.3%
>480ms at any postbaseline not present at baseline	1 0.4%
CFB >=60 ms for at least one post-baseline	0 0%
CFB>=30ms for at least one &<60ms for all PBL	42 15.3%

7. Secondary Outcome

Title	Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The Intent-to-Treat (ITT) population consisted of all subjects that received any open-label study medication

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Any Suicidality	4.0
Any suicidal behavior	0.7
Any suicidal ideation	3.6

8. Secondary Outcome

Title	Time on Eslicarbazepine Acetate Monotherapy.
Description	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.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

ITT Subjects who started the monotherapy period (Visit 6/Week 8) in 093-045 or 093-046 and did not add a non-rescue/emergency Antiepileptic drug (AED) during the start date of the monotherapy period

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	238
Median (95% Confidence Interval) [Days]	NA

9. Secondary Outcome

Title	Change in Seizure Frequency From Baseline.
Description	Relative (%) change in standard seizure frequency(SSF) from baseline
Time Frame	Month 12 from baseline

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population consisted of all subjects who had taken any open-label study medication

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Median (Inter-Quartile Range) [percent change]	-66.4

10. Secondary Outcome

Title	Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).
Description	Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Number [percentage of participants]	62.4 22.8%

11. Secondary Outcome

Title	Percentage of Subjects That Are Seizure-free During Study
Description	Percentage of subjects that are seizure-free during study
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Number [percentage of participants]	7.3 2.7%

12. Secondary Outcome

Title	Completion Rate (% of Subjects Completing the One Year Treatment)
Description	Completion rate (% of subjects completing the one year treatment)
Time Frame	One year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Number [percentagae of participants]	74.8 27.3%

13. Secondary Outcome

Title	Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)
Description	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.
Time Frame	One year

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) subjects who started the monotherapy period in 093-045 or 093-046 (visi t6/week 8)

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	255
Median (95% Confidence Interval) [days]	NA

14. Secondary Outcome

Title	Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).
Description	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.
Time Frame	baseline and Month 12

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Mean (Standard Deviation) [units on a scale]	6.6 (15.29)

15. Secondary Outcome

Title	Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Mean (Standard Deviation) [units on a scale]	-1.5 (6.17)

16. Secondary Outcome

Title	Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening
Description	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.
Time Frame	baseline and Month 12

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	274
Mean (Standard Deviation) [units on a scale]	-1.5 (6.17)

17. Secondary Outcome

Title	Completion Rate (% of Subjects Completing Each Visit Post-one Year).
Description	Completion rate (% of subjects completing each visit post-one year).
Time Frame	post 1 year

Outcome Measure Data

Analysis Population Description

The intent-to-treat (ITT) subjects who entered the post - 1- year open -label period.

Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
Measure Participants	198
Number [percentagae of participants]	66.7 24.3%

Adverse Events

Time Frame	1 year
Arm/Group Title	Eslicarbazepine Acetate
Arm/Group Description	Open-label treatment with eslicarbazepine acetate will be at doses between 800 and 2400 mg QD Eslicarbazepine acetate: 800 to 2400 mg once daily (QD)
All Cause Mortality
	Eslicarbazepine Acetate
	Affected / at Risk (%)	# Events
Total	2/274 (0.7%)
Serious Adverse Events
	Eslicarbazepine Acetate
	Affected / at Risk (%)	# Events
Total	32/274 (11.7%)
Cardiac disorders
sinus tachycardia	1/274 (0.4%)	1
Ear and labyrinth disorders
vertigo	1/274 (0.4%)	1
Gastrointestinal disorders
abdominal pain upper	1/274 (0.4%)	1
colitis	1/274 (0.4%)	1
pancreatitis	1/274 (0.4%)	1
vomiting	1/274 (0.4%)	1
General disorders
non-cardiac chest pain	3/274 (1.1%)	3
irritability	1/274 (0.4%)	1
sudden unexplained death in epilepsy	1/274 (0.4%)	1
Hepatobiliary disorders
cholelithiasis obstructive	1/274 (0.4%)	1
Infections and infestations
chronic sinusitis	1/274 (0.4%)	1
histoplasmosis	1/274 (0.4%)	1
pneumonia	1/274 (0.4%)	1
tooth infection	1/274 (0.4%)	1
Injury, poisoning and procedural complications
accidental overdose	1/274 (0.4%)	1
collapse of lung	1/274 (0.4%)	1
fall	1/274 (0.4%)	1
post concussion syndrome	1/274 (0.4%)	1
Therapeutic agent toxicity	1/274 (0.4%)	1
Investigations
electroencephalogram	1/274 (0.4%)	1
Metabolism and nutrition disorders
failure to thrive	1/274 (0.4%)	1
Musculoskeletal and connective tissue disorders
arthritis	1/274 (0.4%)	1
muscle twitching	1/274 (0.4%)	1
Osteoarthritis	1/274 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
fallopian tube cancer	1/274 (0.4%)	1
non-small cel lung cancer metastatic	1/274 (0.4%)	1
ovarian cancer	1/274 (0.4%)	1
Nervous system disorders
partial seizures with secondary generalisation	7/274 (2.6%)	7
complex partial seizures	3/274 (1.1%)	3
simple partial seizures	2/274 (0.7%)	2
akathisia	1/274 (0.4%)	1
grand mal convulsion	1/274 (0.4%)	1
postictal paralysis	1/274 (0.4%)	1
status epilepticus	1/274 (0.4%)	1
Psychiatric disorders
depression	1/274 (0.4%)	1
suicidal ideation	1/274 (0.4%)	1
Renal and urinary disorders
nephrolithiasis	1/274 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
emphysema	1/274 (0.4%)	1
Vascular disorders
accelerated hypertension	1/274 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Eslicarbazepine Acetate
	Affected / at Risk (%)	# Events
Total	166/274 (60.6%)
Gastrointestinal disorders
nausea	24/274 (8.8%)	31
vomiting	16/274 (5.8%)	20
diarrhoea	15/274 (5.5%)	19
General disorders
fatigue	23/274 (8.4%)	25
Infections and infestations
nasopharyngitis	24/274 (8.8%)	35
influenza	14/274 (5.1%)	15
Injury, poisoning and procedural complications
fall	20/274 (7.3%)	33
Musculoskeletal and connective tissue disorders
back pain	16/274 (5.8%)	16
Nervous system disorders
headache	64/274 (23.4%)	144
dizziness	46/274 (16.8%)	81
complex partial seizures	14/274 (5.1%)	18
Psychiatric disorders
depression	18/274 (6.6%)	19
insomnia	15/274 (5.5%)	18

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.