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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryOverall 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.
SecondaryOverall 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.
SecondaryMCG 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.
SecondaryDual 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.
SecondaryProfile 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.

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOverall 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-scoreMEAN
SECONDARYOverall 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-scoreMEAN
SECONDARYMCG 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 scaleMEAN
SECONDARYDual 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 boxMEAN
SECONDARYProfile 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 scaleMEAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.Eslicarbazepine.001Standard Deviation .50Z-score
Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.Carbamazepine-.23Standard Deviation .61Z-score
Overall Z-score for Executive Function.Eslicarbazepine.22Standard Deviation .53Z-score
Overall Z-score for Executive Function.Carbamazepine-.32Standard Deviation .76Z-score
MCG Paragraph Recall Scores.Non-drug Condition AverageImmediate Recall34Standard Deviation 17units on a scale
MCG Paragraph Recall Scores.EslicarbazepineImmediate Recall33Standard Deviation 12units on a scale
MCG Paragraph Recall Scores.CarbamazepineImmediate Recall31Standard Deviation 15units on a scale
MCG Paragraph Recall Scores.Non-drug Condition AverageDelayed Recall33Standard Deviation 18units on a scale
MCG Paragraph Recall Scores.EslicarbazepineDelayed Recall31Standard Deviation 13units on a scale
MCG Paragraph Recall Scores.CarbamazepineDelayed Recall30Standard Deviation 16units on a scale

Participant flow22

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Treatment 1STARTEDEslicarbazepine, Then Carbamazepine23
Treatment 1STARTEDCarbamazepine, Then Eslicarbazepine23
Treatment 1Received InterventionEslicarbazepine, Then Carbamazepine18
Treatment 1Received InterventionCarbamazepine, Then Eslicarbazepine18
Treatment 1COMPLETEDEslicarbazepine, Then Carbamazepine13
Treatment 1COMPLETEDCarbamazepine, Then Eslicarbazepine11
Treatment 1NOT COMPLETEDEslicarbazepine, Then Carbamazepine10
Treatment 1NOT COMPLETEDCarbamazepine, Then Eslicarbazepine12
Washout PeriodSTARTEDEslicarbazepine, Then Carbamazepine13
Washout PeriodSTARTEDCarbamazepine, Then Eslicarbazepine11

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAgitationNervous system disordersEslicarbazepine029
otherAgitationNervous system disordersCarbamazepine130
otherAltered pitch perception (pitch seemed lower)Nervous system disordersEslicarbazepine029
otherAltered pitch perception (pitch seemed lower)Nervous system disordersCarbamazepine130
otherClouded visionNervous system disordersEslicarbazepine129
otherClouded visionNervous system disordersCarbamazepine030
otherConstipationGastrointestinal disordersEslicarbazepine129
otherConstipationGastrointestinal disordersCarbamazepine130
otherCoordination/balance problemsNervous system disordersEslicarbazepine029
otherCoordination/balance problemsNervous system disordersCarbamazepine130

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityEslicarbazepine029
Total, all-cause mortalityCarbamazepine030
Total, other adverse eventsEslicarbazepine1229
Total, other adverse eventsCarbamazepine2130
Total, serious adverse eventsEslicarbazepine029
Total, serious adverse eventsCarbamazepine030

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.

ComparisonSource
Eslicarbazepine vs Carbamazepine: deaths from any causeTrial comparisons
Eslicarbazepine vs Carbamazepine: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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