Trial · NCT02912364
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
NCT02912364, Phase 4, Completed, Stanford University; results first posted 2019-06-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults. Trials, record NCT02912364. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02912364
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
- NCT number
- NCT02912364
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 46 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Epilepsy
- Interventions
- Eslicarbazepine, Carbamazepine
- First posted
- 2016-09-23
- Last updated
- 2019-06-04
- Results first posted
- 2019-06-04
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs. | At the end of each 6-week drug treatment period. | Z score of cognitive tests at end of each 6-week drug treatment period for each intervention (i.e., Eslicarbazepine and Carbamazepine). The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poor cognitive performance compared to the mean and positive numbers represent higher cognitive performance compared to the mean. |
| Secondary | Overall Z-score for Executive Function. | At the end of each 6-week drug treatment period. | Executive function consists of a composite of measures from the computerized cognitive tests. The Z-score indicates the number of standard deviations away from a reference population. A Z-score of 0 is equal to the mean. Negative numbers indicate poor cognitive performance compared to the mean and positive numbers represent higher cognitive performance compared to the mean. |
| Secondary | MCG Paragraph Recall Scores. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. | Participants were read a paragraph and were asked to recall content immediately following and twenty minutes after hearing the reading. MCG = Medical College of Georgia. Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: 0 - 60, higher scores indicate better memory function. |
| Secondary | Dual Task Percent of Time in Box. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. | Participants were asked to use their computer mouse to keep the cursor inside a moving box on the computer screen while simultaneously responding with a button press when a number on the screen exceeded a certain value. Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. |
| Secondary | Profile of Mood States (POMS) Score. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. | Participants were asked to rate the extent to which they feel a variety of emotions/feelings. The overall score is presented. Assessments were performed prior to treatment (non-drug condition average) and at the end of each treatment period. Score range: -32 to 200. Lower scores correspond to better mood state. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs. | At the end of each 6-week drug treatment period. | Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (completed treatment 2 in the participant flow) are included in the analysis. | Z-score | MEAN |
| SECONDARY | Overall Z-score for Executive Function. | At the end of each 6-week drug treatment period. | Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis. | Z-score | MEAN |
| SECONDARY | MCG Paragraph Recall Scores. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. | Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis. | units on a scale | MEAN |
| SECONDARY | Dual Task Percent of Time in Box. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. | Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis. | percentage of time in box | MEAN |
| SECONDARY | Profile of Mood States (POMS) Score. | Prior to treatment (non-drug condition average) and at the end of each six-week treatment period. | Participants who completed the protocol are included in the analysis. That is, participants who completed both treatment arms (Eslicarbazepine and Carbamazepine) are included in the analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs. | Eslicarbazepine | .001 | Standard Deviation .50 | Z-score | |
| Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs. | Carbamazepine | -.23 | Standard Deviation .61 | Z-score | |
| Overall Z-score for Executive Function. | Eslicarbazepine | .22 | Standard Deviation .53 | Z-score | |
| Overall Z-score for Executive Function. | Carbamazepine | -.32 | Standard Deviation .76 | Z-score | |
| MCG Paragraph Recall Scores. | Non-drug Condition Average | Immediate Recall | 34 | Standard Deviation 17 | units on a scale |
| MCG Paragraph Recall Scores. | Eslicarbazepine | Immediate Recall | 33 | Standard Deviation 12 | units on a scale |
| MCG Paragraph Recall Scores. | Carbamazepine | Immediate Recall | 31 | Standard Deviation 15 | units on a scale |
| MCG Paragraph Recall Scores. | Non-drug Condition Average | Delayed Recall | 33 | Standard Deviation 18 | units on a scale |
| MCG Paragraph Recall Scores. | Eslicarbazepine | Delayed Recall | 31 | Standard Deviation 13 | units on a scale |
| MCG Paragraph Recall Scores. | Carbamazepine | Delayed Recall | 30 | Standard Deviation 16 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow22
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment 1 | STARTED | Eslicarbazepine, Then Carbamazepine | 23 | |
| Treatment 1 | STARTED | Carbamazepine, Then Eslicarbazepine | 23 | |
| Treatment 1 | Received Intervention | Eslicarbazepine, Then Carbamazepine | 18 | |
| Treatment 1 | Received Intervention | Carbamazepine, Then Eslicarbazepine | 18 | |
| Treatment 1 | COMPLETED | Eslicarbazepine, Then Carbamazepine | 13 | |
| Treatment 1 | COMPLETED | Carbamazepine, Then Eslicarbazepine | 11 | |
| Treatment 1 | NOT COMPLETED | Eslicarbazepine, Then Carbamazepine | 10 | |
| Treatment 1 | NOT COMPLETED | Carbamazepine, Then Eslicarbazepine | 12 | |
| Washout Period | STARTED | Eslicarbazepine, Then Carbamazepine | 13 | |
| Washout Period | STARTED | Carbamazepine, Then Eslicarbazepine | 11 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 participant flowAdverse events56
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 | Agitation | Nervous system disorders | Eslicarbazepine | 0 | 29 | |
| other | Agitation | Nervous system disorders | Carbamazepine | 1 | 30 | |
| other | Altered pitch perception (pitch seemed lower) | Nervous system disorders | Eslicarbazepine | 0 | 29 | |
| other | Altered pitch perception (pitch seemed lower) | Nervous system disorders | Carbamazepine | 1 | 30 | |
| other | Clouded vision | Nervous system disorders | Eslicarbazepine | 1 | 29 | |
| other | Clouded vision | Nervous system disorders | Carbamazepine | 0 | 30 | |
| other | Constipation | Gastrointestinal disorders | Eslicarbazepine | 1 | 29 | |
| other | Constipation | Gastrointestinal disorders | Carbamazepine | 1 | 30 | |
| other | Coordination/balance problems | Nervous system disorders | Eslicarbazepine | 0 | 29 | |
| other | Coordination/balance problems | Nervous system disorders | Carbamazepine | 1 | 30 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eslicarbazepine | 0 | 29 |
| Total, all-cause mortality | Carbamazepine | 0 | 30 |
| Total, other adverse events | Eslicarbazepine | 12 | 29 |
| Total, other adverse events | Carbamazepine | 21 | 30 |
| Total, serious adverse events | Eslicarbazepine | 0 | 29 |
| Total, serious adverse events | Carbamazepine | 0 | 30 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Eslicarbazepine vs Carbamazepine: deaths from any cause | Trial comparisons |
| Eslicarbazepine vs Carbamazepine: serious adverse events | Trial comparisons |
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/NCT02912364
GET https://conductscience.org/api/trials/v1/NCT02912364/flow?page=2