Brief Summary
This is a long term, open-label, safety extension study in subjects with partial onset seizures.
Brief Title
Eslicarbazepine Acetate Monotherapy Long Term Study
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Epilepsy
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.
* 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.
Inclusion Criteria
Inclusion/
Gender
All
Gender Based
false
Keywords
Seizures
Epilepsy
Anticonvulsant
Monotherapy
Epilepsy with simple or complete partial onset seizures
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
16 Years
NCT Id
NCT00910247
Org Class
Industry
Org Full Name
Sumitomo Pharma America, Inc.
Org Study Id
093-050
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Long Term Eslicarbazepine Acetate Extension Study
Primary Outcomes
Outcome Description
Number and percent of subjects with treatment emergent adverse events
Outcome Measure
Number and Percent of Subjects With Treatment Emergent Adverse Events
Outcome Time Frame
One year
Secondary Outcomes
Outcome Description
Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations
Outcome Time Frame
1 year
Outcome Measure
Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations
Outcome 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.
Outcome Time Frame
1 year
Outcome Measure
Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L
Outcome Description
Percentage of subjects with increase of body weight ≥7%
Outcome Time Frame
1 year
Outcome Measure
Percentage of Subjects With Increase of Body Weight ≥7%
Outcome Description
Number and percentage of subjects with orthostatic effects.
Outcome Time Frame
1 year
Outcome Measure
Number and Percentage of Subjects With Orthostatic Effects.
Outcome 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:
1. \>500 millisecond (msec) at any post-baseline timepoint but not present at baseline
2. \>480 msec at any post-baseline timepoint but not present at baseline
3. \>450 msec at any post-baseline timepoint but not present at baseline
4. Change from Baseline \>=60 ms for at least one post-baseline measurement
5. 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.
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:
1. \>500 millisecond (msec) at any post-baseline timepoint but not present at baseline
2. \>480 msec at any post-baseline timepoint but not present at baseline
3. \>450 msec at any post-baseline timepoint but not present at baseline
4. Change from Baseline \>=60 ms for at least one post-baseline measurement
5. 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.
Outcome Time Frame
Baseline, Month 12
Outcome Measure
Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline.
Outcome 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.
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.
Outcome Time Frame
1 year
Outcome Measure
Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS).
Outcome 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.
Outcome Time Frame
One year
Outcome Measure
Time on Eslicarbazepine Acetate Monotherapy.
Outcome Description
Relative (%) change in standard seizure frequency(SSF) from baseline
Outcome Time Frame
Month 12 from baseline
Outcome Measure
Change in Seizure Frequency From Baseline.
Outcome Description
Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).
Outcome Time Frame
One year
Outcome Measure
Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline).
Outcome Description
Percentage of subjects that are seizure-free during study
Outcome Time Frame
1 year
Outcome Measure
Percentage of Subjects That Are Seizure-free During Study
Outcome Description
Completion rate (% of subjects completing the one year treatment)
Outcome Time Frame
One year
Outcome Measure
Completion Rate (% of Subjects Completing the One Year Treatment)
Outcome 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.
Outcome Time Frame
One year
Outcome Measure
Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events)
Outcome 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.
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.
Outcome Time Frame
baseline and Month 12
Outcome Measure
Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31).
Outcome 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.
Outcome Time Frame
1 year
Outcome Measure
Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS).
Outcome 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.
Outcome Time Frame
baseline and Month 12
Outcome 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
Outcome Description
Completion rate (% of subjects completing each visit post-one year).
Outcome Time Frame
post 1 year
Outcome Measure
Completion Rate (% of Subjects Completing Each Visit Post-one Year).
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
16
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alexis Boro
Investigator Email
aboro@montefiore.org
Investigator Phone