Phase 4
Completed N=46
Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Source: ClinicalTrials.gov NCT02912364 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs. — .001; -.23 Z-score — p=< .001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs. |
.001; -.23 | < .001 sig |
| SECONDARY Overall Z-score for Executive Function. |
.22; -.32 | < .001 sig |
| SECONDARY MCG Paragraph Recall Scores. |
34; 33; 31; 33; 31; 30 | — |
| SECONDARY Dual Task Percent of Time in Box. |
62; 62; 60 | — |
| SECONDARY Profile of Mood States (POMS) Score. |
8; 11; 15 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy adults between the ages of 18 and 55 years old.
- Male or female
Exclusion Criteria
- Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
- Presence or history of drug or alcohol abuse.
- The use of concomitant medications, which are known to affect ESL or Carbamazepine or the use of any concomitant medications that may alter cognitive function (see Section VII.E for a partial list).
- Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
- Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
- Prior participation in studies involving anticonvulsant medications.
- Subjects who have received any investigational drug within the previous thirty days.
- Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.
- Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.
Data sourced from ClinicalTrials.gov (NCT02912364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.