Eslicarbazepine Acetate Monotherapy Long Term Study
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|ClinicalTrials.gov Identifier: NCT00910247|
Recruitment Status : Completed
First Posted : May 29, 2009
Results First Posted : July 17, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Eslicarbazepine acetate||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||274 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|Official Title:||Long Term Eslicarbazepine Acetate Extension Study|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||April 15, 2017|
|Actual Study Completion Date :||April 15, 2017|
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)
- Number and Percent of Subjects With Treatment Emergent Adverse Events [ Time Frame: One year ]Number and percent of subjects with treatment emergent adverse events
- Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations [ Time Frame: 1 year ]Number and percentage of subjects with potentially clinically significant clinical laboratory evaluations
- Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L [ Time Frame: 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.
- Percentage of Subjects With Increase of Body Weight ≥7% [ Time Frame: 1 year ]Percentage of subjects with increase of body weight ≥7%
- Number and Percentage of Subjects With Orthostatic Effects. [ Time Frame: 1 year ]Number and percentage of subjects with orthostatic effects.
- Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. [ Time Frame: 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.
- Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS). [ Time Frame: 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.
- Time on Eslicarbazepine Acetate Monotherapy. [ Time Frame: 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.
- Change in Seizure Frequency From Baseline. [ Time Frame: Month 12 from baseline ]Relative (%) change in standard seizure frequency(SSF) from baseline
- Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline). [ Time Frame: One year ]Responder rate (percentage of subjects with a ≥50% reduction of seizure frequency from baseline).
- Percentage of Subjects That Are Seizure-free During Study [ Time Frame: 1 year ]Percentage of subjects that are seizure-free during study
- Completion Rate (% of Subjects Completing the One Year Treatment) [ Time Frame: One year ]Completion rate (% of subjects completing the one year treatment)
- Treatment Retention Time (Time to Withdrawal Due to Lack of Efficacy or Adverse Events) [ Time Frame: 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.
- Change in Total Score From Baseline in 31-Item Quality of Life in Epilepsy (QOLIE-31). [ Time Frame: 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.
- Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS). [ Time Frame: 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.
- Change in Total Score From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) in Those Subjects With a MADRS Score of ≥14 at Screening [ Time Frame: 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.
- Completion Rate (% of Subjects Completing Each Visit Post-one Year). [ Time Frame: post 1 year ]Completion rate (% of subjects completing each visit post-one year).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910247
|Study Director:||CNS Medical Director||Sunovion Pharmaceuticals|