Trial · NCT00910247
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percent of Subjects With Treatment Emergent Adverse Events | One year | Number and percent of subjects with treatment emergent adverse events |
| Secondary | 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 |
| Secondary | 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. |
| Secondary | Percentage of Subjects With Increase of Body Weight ≥7% | 1 year | Percentage of subjects with increase of body weight ≥7% |
| Secondary | Number and Percentage of Subjects With Orthostatic Effects. | 1 year | Number and percentage of subjects with orthostatic effects. |
| Secondary | 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: 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Change in Seizure Frequency From Baseline. | Month 12 from baseline | Relative (%) change in standard seizure frequency(SSF) from baseline |
| Secondary | 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). |
| Secondary | Percentage of Subjects That Are Seizure-free During Study | 1 year | Percentage of subjects that are seizure-free during study |
| Secondary | Completion Rate (% of Subjects Completing the One Year Treatment) | One year | Completion rate (% of subjects completing the one year treatment) |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| 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 | 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. |
| Secondary | Completion Rate (% of Subjects Completing Each Visit Post-one Year). | post 1 year | Completion rate (% of subjects completing each visit post-one year). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00910247/registered