Trial · NCT00910247
Eslicarbazepine Acetate Monotherapy Long Term Study
NCT00910247, Phase 3, Completed, Sumitomo Pharma America, Inc.; results first posted 2018-07-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Eslicarbazepine Acetate Monotherapy Long Term Study. Trials, record NCT00910247. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00910247
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eslicarbazepine Acetate Monotherapy Long Term Study
- NCT number
- NCT00910247
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 274 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Epilepsy
- Interventions
- Eslicarbazepine acetate
- First posted
- 2009-05-29
- Last updated
- 2018-07-17
- Results first posted
- 2018-07-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number and Percent of Subjects With Treatment Emergent Adverse Events | One year | The Intent-to -Treat (ITT) population consisted of all subjects who had taken any open-label study medication | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations | 1 year | The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | ITT subjects with baseline sodium and at least one post baseline sodium value | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Increase of Body Weight ≥7% | 1 year | The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication. | percentagae of participants | NUMBER |
| SECONDARY | Number and Percentage of Subjects With Orthostatic Effects. | 1 year | The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. | Baseline, Month 12 | The intent-to-treat (ITT) subjects with at least one post-baseline assessment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Events in Each Classification of the Columbia Suicide Severity Rating Scale (C SSRS). | 1 year | The Intent-to-Treat (ITT) population consisted of all subjects that received any open-label study medication | percentage of events | NUMBER |
| SECONDARY | Time on Eslicarbazepine Acetate Monotherapy. | One year | 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 | Days | MEDIAN |
| SECONDARY | Change in Seizure Frequency From Baseline. | Month 12 from baseline | Intent-to-treat (ITT) population consisted of all subjects who had taken any open-label study medication | percent change | MEDIAN |
| SECONDARY | Responder Rate (Percentage of Subjects With a ≥50% Reduction of Seizure Frequency From Baseline). | One year | The intent-to-treat (ITT) population consisted of all subjects who have taken any open-label study medication. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number and Percent of Subjects With Treatment Emergent Adverse Events | Eslicarbazepine Acetate | 220 | Participants | ||
| Number and Percentage of Subjects With Potentially Clinically Significant Clinical Laboratory Evaluations | Eslicarbazepine Acetate | 186 | Participants | ||
| Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L | Eslicarbazepine Acetate | <=135 mEq/L and >130 mEq/L | 48 | Participants | |
| Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L | Eslicarbazepine Acetate | <=130 mEq/L and >125 mEq/L | 22 | Participants | |
| Number and Percent of Subjects With Normal Baseline Sodium Reaching Blood Sodium ≤135 mmol/L, ≤130 mmol/L, and ≤125 mmol/L | Eslicarbazepine Acetate | <=125 mEq/L | 4 | Participants | |
| Percentage of Subjects With Increase of Body Weight ≥7% | Eslicarbazepine Acetate | 27 | percentagae of participants | ||
| Number and Percentage of Subjects With Orthostatic Effects. | Eslicarbazepine Acetate | 67 | Participants | ||
| Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. | Eslicarbazepine Acetate | >500ms at any postbaseline not present at baseli | 0 | Participants | |
| Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. | Eslicarbazepine Acetate | >450ms at any postbaseline not present at baseline | 9 | Participants | |
| Number and Percentage of Subjects With QTc-F Changes (in Categories) From Baseline. | Eslicarbazepine Acetate | >480ms at any postbaseline not present at baseline | 1 | Participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eslicarbazepine Acetate | 274 | |
| Overall Study | COMPLETED | Eslicarbazepine Acetate | 205 | |
| Overall Study | NOT COMPLETED | Eslicarbazepine Acetate | 69 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nausea | Gastrointestinal disorders | Eslicarbazepine Acetate | 24 | 274 | 31 |
| other | vomiting | Gastrointestinal disorders | Eslicarbazepine Acetate | 16 | 274 | 20 |
| other | diarrhoea | Gastrointestinal disorders | Eslicarbazepine Acetate | 15 | 274 | 19 |
| other | fatigue | General disorders | Eslicarbazepine Acetate | 23 | 274 | 25 |
| other | nasopharyngitis | Infections and infestations | Eslicarbazepine Acetate | 24 | 274 | 35 |
| other | influenza | Infections and infestations | Eslicarbazepine Acetate | 14 | 274 | 15 |
| other | fall | Injury, poisoning and procedural complications | Eslicarbazepine Acetate | 20 | 274 | 33 |
| other | back pain | Musculoskeletal and connective tissue disorders | Eslicarbazepine Acetate | 16 | 274 | 16 |
| other | headache | Nervous system disorders | Eslicarbazepine Acetate | 64 | 274 | 144 |
| other | dizziness | Nervous system disorders | Eslicarbazepine Acetate | 46 | 274 | 81 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eslicarbazepine Acetate | 2 | 274 |
| Total, other adverse events | Eslicarbazepine Acetate | 166 | 274 |
| Total, serious adverse events | Eslicarbazepine Acetate | 32 | 274 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00910247
GET https://conductscience.org/api/trials/v1/NCT00910247/results?page=2